Systematic Review of Paramedical Therapies for Parkinson s Disease

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1 Movement Disorders Vol. 17, No. 5, 2002, pp Movement Disorder Society Systematic Review of Paramedical Therapies for Parkinson s Disease Katherine H.O. Deane, BSc(Hons), PhD, 1 Caroline Ellis-Hill, BSc, MSc, PhD, 2 Diana Jones, PhD, 3 Renata Whurr, MSc, PhD, 4 Yoav Ben-Shlomo, BSc, MRCP, MSc, MFPHM, 5 E. Diane Playford, MD, FRCP, 4 and Carl E. Clarke, BSc(Hons), FRCP 1 * 1 Department of Neurology, City Hospital NHS Trust, and The University of Birmingham, Birmingham, United Kingdom 2 Health and Rehabilitation Research Unit, University of Southampton, Southampton, United Kingdom 3 Institute of Rehabilitation, Hunters Moor Regional Neurological Rehabilitation Centre, Newcastle upon Tyne, United Kingdom 4 The National Hospital for Neurology and Neurosurgery, London, United Kingdom 5 Department of Social Medicine, Bristol University, Bristol, United Kingdom Abstract: We evaluated the efficacy of physiotherapy, occupational therapy, and speech and language therapy in Parkinson s disease by synthesizing six Cochrane systematic reviews. All randomised, controlled trials examining the efficacy of a paramedical therapy versus control intervention and all those comparing the efficacy of two forms of active therapy in Parkinson s disease were included. Trials were identified by searching biomedical databases, reference lists, hand searching, and contacting investigators. The main outcome measures were quality of life, speech intelligibility, activities of daily living, and individual measures of motor and speech impairment. We identified 16 physiotherapy randomised controlled trials (399 patients), two occupational therapy trials (84 patients), and five speech and language therapy for dysarthria trials (154 patients). None of these studies examined nonpharmacological swallowing therapy for dysphagia. We were unable to perform metaanalysis of the results because the trials used heterogeneous therapy methods and outcome measures. The trials also had marked methodological flaws that could have introduced bias. In summary, we failed to find conclusive evidence of benefit for any form of paramedical therapy sufficient to recommend them in routine clinical practice. However, this lack of evidence is not proof of a lack of effect. Further large pragmatic randomised controlled trials are required to determine the effectiveness of paramedical therapies in Parkinson s disease Movement Disorder Society Key words: Parkinson s disease; physiotherapy; occupational therapy; speech and language therapy; systematic review Anecdotal evidence from patients, health professionals, and the Parkinson s Disease Society strongly supports the use of paramedical therapies in the comprehensive management of Parkinson s disease in addition to optimal medical and surgical treatment. These paramedical therapies include physiotherapy, occupational therapy, and speech and language therapy. Despite this support for paramedical therapies, 1 several surveys have demonstrated that only 3 to 29% of patients with Parkinson s disease have seen a paramedical therapist. 2 5 *Correspondence to: Carl E. Clarke, Department of Neurology, City Hospital NHS Trust, Dudley Road, Birmingham B18 7QH, United Kingdom. c.e.clarke@bham.ac.uk Received 11 October 2001; Revised 19 January 2002; Accepted 30 January 2002 Published online 10 April 2002 in Wiley InterScience (www. interscience.wiley.com). DOI /mds This low rate of referral may partly reflect clinicians belief that there is little evidence for using such therapy, although the under-provision of such services in the United Kingdom may be an additional factor. A systematic review of the existing data is required to clarify the evidence about the role of paramedical therapies in Parkinson s disease. Paramedical therapists treating people with Parkinson s disease provide appropriate exercises, aids, education, and advice that aim to help patients to better understand and cope with their disease. The core areas of physiotherapy relate to gait, balance, posture, and transfers. 6 Occupational therapists use therapeutic techniques and provide aids and adaptations to allow normal work, self-care, and leisure activities to continue. Speech and language therapists treat patients with specific exercises and advice about speech and swallowing. 984

2 REVIEW OF PARAMEDICAL THERAPIES FOR PD 985 This review synthesises six systematic reviews of paramedical therapies in Parkinson s disease published in the Cochrane Library by the current authors It examines randomised controlled trials comparing each paramedical therapy with control intervention or no therapy and those comparing two forms of active therapy. PATIENTS AND METHODS Criteria for Considering Trials for Review We included only randomised or quasirandomised controlled trials that evaluated speech and language therapy for dysarthria, physiotherapy, and occupational therapy (see Appendix). We also included studies that evaluated the nonpharmacological treatment of dysphagia, but excluded studies for which the therapist s advice was to insert a nasogastric or percutaneous gastrostomy tube. Participants in the trials were patients with Parkinson s disease (as defined by the authors of the trials), of any disease duration, of all ages, and on any form of drug therapy. We did not select trials by duration of treatment, and we accepted trial reports in any language. Search Strategy We identified trials by searching general biomedical databases (Medline, EMBase, CINAHL, and ISI-SCI), rehabilitation databases (AMED, Mantis, Rehabdata, and Rehadat), English-language databases of foreign language research and third world publications (Gerolit, Pascal, LILACS, MedCarib, JICST-EPlus, AIM), grey literature databases (IMEMR; SIGLE, ISI-ISTP, DISSABS, Conference Papers Index, and Aslib Index to Theses), trials registers (the Cochrane Controlled Trials Register, the CentreWatch Clinical Trials listing service, the metaregister of Controlled Trials, ClinicalTrials.gov, CRISP, PEDro, NIDRR, NRR), and the reference lists of identified trials and other reviews. Our search strategy was based on that of the Cochrane Movement Disorders Group, which essentially cross-referenced as MeSH headings and text words: Parkinson s disease and all its derivations, with rehabilitation, physical therapy, physiotherapy, exercise, occupational therapy, speech, voice, language, dysarthria, swallow, and dysphagia. Methods Two authors, per Cochrane review, independently extracted the data and settled differences by discussion. Where possible, we asked the original investigators for additional data or clarification of methods. Each trial was compared with a standard set of quality criteria to examine points where its design may have introduced bias (Table 1). These criteria are defined in the Appendix. RESULTS Description of the Trials Twenty-three randomised controlled trials examined paramedical therapies for 637 Parkinson s disease patients. We excluded two trials: one for incomplete randomisation of the trial participants, 13 and the other because we determined that osteopathic manipulation was not part of mainstream physiotherapy practice. 14 The included trials had methodological flaws that could have introduced bias, used heterogeneous therapy methods, and measured many different outcomes; therefore, we could not summarise the results quantitatively by metaanalysis (Tables 2 and 3). Consequently a systematic qualitative appraisal was performed. Methodological Quality of the Trials The trial methods varied in quality (Table 1 and Appendix 1) and all trials had at least one methodological flaw that could have introduced bias. No trial examined had the combination of an adequate method of randomisation, adequate concealment of the allocation, had blinded their assessors, and had an adequate placebo. These four quality items are generally regarded as having the greatest impact on the validity of a trial s results. For example, only seven trials truly randomised allocation to treatment groups, and of these, only four adequately concealed allocation. Fourteen of the 16 trials with an inactive control arm failed to use a placebo intervention. We defined an adequate placebo therapy intervention as being one that provided an inactive treatment to patients for TABLE 1. Methodological quality of included studies Quality item Adequate Not stated Inadequate Total Randomisation method Concealment of allocation Cointerventions constant (e.g., drug therapy) Placebo therapy Withdrawals described & <10% of original population Blinded assessors Missing values present for <10% of original population Intention-to-treat data analysis Between group statistical data comparison

3 986 K.H.O. DEANE ET AL. Study TABLE 2. Characteristics of studies comparing paramedical therapies with control intervention Design No. of patients Mean baseline Hoehn and Yahr stage* Total time with therapist (hr) Duration of therapy (wk) Location Description of therapy Control intervention Physiotherapy Gibberd ,21 Crossover 24 NA NA 4 Outpatient Bobath & Peto PNF Adequate exercises Hurwitz Parallel Home National Parkinson s Adequate Foundation exercises Cerri Parallel 6 NA 15 3 Outpatient Neurofacilitation exercises None Comella Crossover 18 NA 12 4 Outpatient PNF-based exercises None Forkink Parallel NA 10 Outpatient Strengthening of legs & None balance training Katsikitis Parallel 16 NA 8 4 Outpatient Orofacial None Patti Parallel NA 4 Inpatient Rehabilitation Inadequate Thaut Parallel Home Walking exercises Inadequate Homann Parallel NA 5 Outpatient Bobath PNF exercises None Schenkman Parallel Outpatient Spinal flexibility None exercises Chandler Parallel NA 52 Home Rehabilitation Inadequate Occupational therapy Gauthier Parallel Outpatient Group OT Unclear Fiorani Parallel 20 NA 12 4 Outpatient Group OT and Inadequate physiotherapy Speech and language therapy Robertson Parallel 22 NA 40 2 Outpatient Respiration, loudness None & prosody Johnson Parallel 12 NA 10 4 Outpatient Prosodic exercises None Ramig Parallel Outpatient Increased loudness (LSVT) None LSVT, Lee Silverman Voice Therapy; OT, occupational therapy; PNF, proprioceptive neuromuscular facilitation. *Although the Hoehn and Yahr scale provides ordinal data, most of the authors of the papers provided the mean value. a similar period of time and in a similar setting as the active therapy arm. Ten of the 23 trials either failed to examine baseline differences or were unbalanced due to small sample sizes. Although the trials examined many outcome measures, there was no consensus on which were the most appropriate. Poor presentation and inadequate statistical analysis often hampered interpretation of the results (Tables 4 and 5). Study TABLE 3. Characteristics of studies comparing two forms of the paramedical therapies Design No. of patients Mean baseline Hoehn and Yahr stage Total time with therapist (hr) Duration of therapy (wk) Location Description of therapy A Description of therapy B Physiotherapy Palmer Parallel Outpatient Karate exercises Standard Hirsch Parallel NA 10 Outpatient Strength & balance Balance alone Mohr ,31 Parallel Outpatient Behavioural Standard (inc. cues) Thaut Parallel Home Walking with auditory cues Homann Parallel 16 NA NA 5 Outpatient Bobath PNF Shiba Cross-over 8 NA NA NA Outpatient Walking with visual cues Marchese Parallel NA 6 Outpatient Cued Standard Speech & language therapy Scott ,46 Parallel 64 NA 10 2 Home Prosodic exercises with visual feedback Ramig Parallel Outpatient Increased vocal loudness (LSVT) LSVT, Lee Silverman Voice Therapy; PNF, proprioceptive neuromuscular facilitation. Walking without cues Walking with auditory cues Prosodic exercises alone Respiration therapy

4 REVIEW OF PARAMEDICAL THERAPIES FOR PD 987 TABLE 4. Statistically significant results in studies comparing paramedical therapies with control intervention Outcome Intervention No. of studies that measured outcome No. of studies that calculated statistical significance or provided data in a form that could be analysed No. of studies with statistically significant results Quality of life Physio OT S&LT Speech intelligibility S&LT Activities of daily living Physio OT S&LT Impairments: summary scores Physio <0.001 OT S&LT <0.005 Impairments: walking velocity Physio and OT Impairments: stride length Physio and OT Impairments: objective speech loudness S&LT <0.005 Physio, physiotherapy; OT, occupational therapy; S&LT, speech and language therapy. P Physiotherapy Eleven trials compared physiotherapy with placebo or no treatment in 280 patients The physiotherapy techniques, duration, and location in the trials varied considerably (Table 1). Four trials had interventions from other therapists or had components of their protocol that could be described as occupational therapy. 16,17,20,21,25 However, the occupational therapy components were poorly defined, and the aims and outcomes of the trials were mostly centred around mobility. A summary of the results is given in Tables 4 and 5. Only Chandler and Plant 16 measured quality of life, but they did not give a full statistical analysis of their results. Patti and colleagues 25 measured activities of daily living on several scales after intensive inpatient physiotherapy. All of these scales showed improvements that were maintained for 5 months. The trials measured several individual motor impairments, but only two outcomes were measured in more than one trial: walking velocity in five trials 16,22,25 27 and stride length in three trials 22,25,27 (Table 4). Walking velocity increased significantly in two trials, by 50 to 64%, 25,27 but this improvement was not seen in the other two trials. 16,26 Stride length also improved significantly in two trials by 23% in both. 25,27 No data for walking velocity or stride length was available in one trial. 22 Seven trials compared two forms of physiotherapy in 142 patients (see Table 2). 22,27 33 The majority of outcomes measured were reported to have improved after the novel therapy under investigation (Table 5). One of the techniques used is cueing. This is the prompting of a movement by an external auditory or visual cue such as TABLE 5. Summary of the results from studies comparing two forms of a paramedical therapy Physiotherapy (7 studies) Speech therapy (2 studies) Quality of life Behavioural standard 30,31 LSVT > respiration (P not stated) Speech intelligibility NA LSVT > respiration (carers assessment) (P not stated) 39 44,51 LSVT respiration (patient assessment) 39 44,51 Activities of daily living Strength & balance > balance (P < 0.05) 29 NA Cued standard 28 Behavioural standard 30,31 Karate standard 50 Impairments: summary scores Cued > standard (P < 0.02) 28 NA Behavioural > standard (P 0.01) 30,31 Impairments: walking velocity Walking + auditory cues > walking (P 0.03) 27 NA Impairments: subjective speech loudness NA LSVT Respiration The authors of these studies defined the statistical significance of data when compared between the two therapy groups. The equal sign refers to no statistically significant difference having been found. LSVT, Lee Silverman Voice Therapy; NA, not appropriate.

5 988 K.H.O. DEANE ET AL. rhythmic music or lines on the floor to improve gait. Four of the trials explicitly mentioned the use of cueing in their therapy techniques 27,28,30,31,33 ; two of which compared physiotherapy techniques with and without cueing. 27,28 In both of these studies, the addition of cueing techniques improved the efficacy of the physiotherapy (Table 5). Occupational Therapy Two trials examined occupational therapy in 84 patients (Table 2). 34,35 These differed markedly in their methodology. Gauthier and associates 35 compared group occupational therapy with an untreated control group, whereas Fiorani and coworkers 34 compared group occupational therapy and physiotherapy with individualised physiotherapy. The method of occupational therapy by Fiorani and colleagues 34 included game playing and basketry as major components of the therapy. Neither trial compared data statistically between groups (Table 4). Speech and Language Therapy for Dysarthria Three trials compared speech and language therapy with placebo in 63 Parkinsonian patients with dysarthria The methods differed considerably (Table 2). No trial measured quality of life, speech intelligibility, or activities of daily living affected by poor communication (Table 4). In two trials, 36,37 loudness of speech increased significantly by 5 12 db (8 17%) from a mean baseline loudness of 60 db. Ramig and associates showed that this improvement was maintained after 6 months. 37 Two trials compared two methods of speech and language therapy in 71 patients Ramig and coworkers measured aspects of quality of life affected by speech with the communication subsection of the Sickness Impact Profile. The communication subsection score improved by a significant 61% (baseline score of 29) immediately after Lee Silverman Voice Therapy (LSVT) compared with respiration therapy; however, this improvement was not maintained after 12 months (Table 5). Both trials measured intelligibility on 100-point visual analogue scales, but only Ramig and colleagues compared the therapy groups statistically Although patients noticed no difference in outcome between the two therapy modes, their carers found them more intelligible after LSVT. Ramig and associates measured several individual measures of speech quality up to 2 years after therapy. 43 Speech and Language Therapy for Dysphagia No trials examined the efficacy of nonpharmacological swallowing therapy for dysphagia in Parkinson s disease. DISCUSSION Outcome Measures Many of the trials outlined in this review have concentrated on specific impairment outcomes such as stride length or vocal loudness. However, it should be noted that, in a recent international survey of people with Parkinson s disease, the physical aspects of the disease only accounted for 17% of the patients quality of life. 47 It is increasingly recognised that, although improvement in a specific impairment is easily measured, it may have little benefit for the patient in their life. Physiotherapy The trials of physiotherapy showed some limited evidence of efficacy, particularly with specific gait characteristics such as walking velocity and stride length. Activities of daily living improved in the one trial in which they were measured. Quality of life did not improve in the one trial in which it was measured, and economic analysis was not undertaken in any of the trials. The trials used a wide variety of therapy methods, which leads to difficulty in determining the type of physiotherapy to be tested in a large multicentre trial. The Physiotherapy Evaluation Project (PEP) examined current physiotherapy practice using a Delphi technique and developed a consensus approach for physiotherapy in Parkinson s disease. 6 Practice guidelines have recently been completed by the same group (online.unn.ac.uk/ faculties/hswe/research/rehab/guidelines/intro.htm). A large, randomised, controlled trial is being designed to examine the effectiveness of physiotherapy using these guidelines. Occupational Therapy The two trials of occupational therapy produced results of little value due to problems in the design of the trials that could have led to bias, the small numbers of patients examined, and the marked heterogeneity of the two methods used. Also, both trials examined group occupational therapy; this strategy is unlikely to address an individual s specific occupational aims and needs. We are conducting a Delphi survey to develop a consensus on core occupational therapy practice for Parkinson s disease in the United Kingdom. The consensus document will inform the development of practice guidelines and the design of a large, multicentre, randomised, controlled trial. Speech and Language Therapy The results from the trials of speech and language therapy are encouraging, as the improvements measured do appear to be clinically significant. However, improved intelligibility must be the primary aim in these

6 REVIEW OF PARAMEDICAL THERAPIES FOR PD 989 trials, and this was not measured in the placebocontrolled trials. It should also be noted that much of the data came from two trials that examined the same unique treatment (Lee Silverman Voice Therapy). 37,39 44 Again, the lack of firm data suggests that a large, multicentre, randomised, controlled trial is required. Although the Royal College of Speech and Language Therapists has published consensus guidelines for the therapy of dysarthria, these guidelines are not specific for the treatment of Parkinson s disease and do not contain details of style, duration, or intensity of therapy. 48 Future Trial Design These reviews emphasise the many methodological shortcomings in the 23 trials of paramedical therapies in Parkinson s patients and prompt us to make recommendations for conducting future paramedical therapy trials in Parkinson s disease and other conditions (Table 6). Trials of rehabilitation therapies differ from standard drug trials in that neither the therapist nor the patient can be blinded as to which treatment arm of the trial they are assigned to. Although this inherent lack of blinding can lead to the introduction of bias, efforts should still be made to provide an adequate placebo arm. People with Parkinson s disease are often socially isolated and involvement in the active therapy arm of a trial might well reduce this sufficiently to improve the patient s perception of their well-being. A valid placebo therapy would have the patients visit the outpatient department as often and have someone spend a similar period of time with them. However, it is recognised that a placebo therapy may be impractical to apply in large multicentre trials and that an untreated best medical practice group would represent a more practicable, although less adequate comparator. This method would lead to difficulties in estimating the size of improvement due to therapy because of placebo effect, which is estimated at between 10 to 30% in Parkinson s disease; however, this design may be more reflective of current therapy provision and practice. We recognise that the poor quality of reporting of some trials may be due to them being published before the adoption of the CONSORT reporting guidelines in Future reports of trials must conform to these guidelines so that their results can be fairly assessed. Publication bias arises from the tendency for trials with inconclusive or negative results not to be published in peer-reviewed journals. Only one trial of the 23 reported here found a negative result. 20,21 Many trials that found negative or equivocal results may not have been published in peer-reviewed journals. We are aware of at least two unpublished negative trials whose investigators have declined to provide data for analysis in the Cochrane reviews. Implications Because of the methodological flaws, the small number of patients examined, and the possibility of publication bias, the trials provide insufficient evidence to support or refute the efficacy of these therapies in Parkinson s disease. We emphasise that the current lack of evidence for efficacy of these treatments does not suggest a lack of effect; rather that further work is required. Large, pragmatic, randomised, controlled trials are TABLE 6. Recommendations to improve the quality of future paramedical therapy trials Recommendation Use firm diagnostic criteria, e.g., U.K. PD Brain Bank Criteria 52 Use clear inclusion and exclusion criteria State disease severity of participants, e.g., Hoehn and Yahr score Use large numbers of patients Define the therapy method in detail Use adequate placebo therapy, i.e. this group should have a similar amount of attention paid to them for the same period of time and in a similar environment as the therapy group Assess patients for at least 6 months after therapy Note if the patients are on or off when outcomes are measured Use outcomes that have value to patients e.g. QOL Use outcome scales that are validated, reliable and sensitive in PD Analyse data on an intention-to-treat basis Statistically compare changes in outcome measures between the therapy and placebo groups. Benefits Excludes patients with Parkinson-plus syndromes Allows enrolment of a uniform cohort of patients Allows assessment of which patients benefited most from the therapy and prediction of when best to start therapy Reduces selection bias. Reduces the chance of false positive or negative results; increases the population of patients to which the results can be applied Allows method to be repeated accurately Reduces size of placebo and Hawthorne effects and so strengthens any results Allows determination of the duration of effect and prediction of how frequently the therapy would have to be repeated to maintain benefits Allows clearer assessment of benefits Allows clearer assessment of benefits Gives more robust results Reduces bias Correct analysis UK, United Kingdom; PD, Parkinson s disease; QOL, quality of life.

7 990 K.H.O. DEANE ET AL. needed to assess the effectiveness of paramedical therapies in Parkinson s disease. Acknowledgments: We thank all of the authors of the included studies who assisted in providing unpublished data and clarification of their methods. We also thank all of the people who assisted us in locating other unpublished, randomised, controlled trials. This project was supported by the NHS Research and Development Programme for People with Physical and Complex Disabilities (PCD2/A1/250), City Hospital NHS Trust, Birmingham Hospital Saturday Fund, The Royal Society, and an unconditional grant from Pharmacia Upjohn Limited. REFERENCES 1. Rehabilitation in early onset Parkinson s. In: Parkinson s: the physiotherapist. London: Parkinson s Disease Society; Oxtoby M. Parkinson s disease patients and their social needs. London: Parkinson s Disease Society; Mutch WJ, Strudwick A, Roy SK, Downie AW. Parkinson s disease: disability, review, and management. Br Med J 1986;293: Clarke CE, Zobkiw RM, Gullaksen E. Quality of life and care in Parkinson s disease. Br J Clin Pract 1995;49: Yarrow S. Members 1998 survey of the Parkinson s Disease Society of the United Kingdom. In: Percival R, Hobson P, editors. Parkinson s disease: studies in psychological and social care. Leicester: BPS Books; p Plant R, Jones D, Ashburn A, Lovgreen B, Handord F, Kinnear E. Physiotherapy for people with Parkinson s disease: UK best practice. Newcastle Upon Tyne: Institute of Rehabilitation; Deane KH, Jones D, Clarke CE, Playford D, Ben-Shlomo Y. Physiotherapy for patients with Parkinson s disease. Cochrane Database Syst Rev 2001;3:CD Deane KH, Jones D, Ellis-Hill C, Clarke CE, Playford D, Ben- Shlomo Y. A comparison of physiotherapy techniques for patients with Parkinson s disease. Cochrane Database Syst Rev 2001;1: CD Deane KH, Ellis-Hill C, Clarke CE, Playford D, Ben-Shlomo Y. Occupational therapy for Parkinson s disease. Cochrane Database Syst Rev 2001;3:CD Deane KH, Whurr R, Clarke CE, Playford D, Ben-Shlomo Y. Speech and language therapy for dysarthria in Parkinson s disease. Cochrane Database Syst Rev 2001;2:CD Deane KH, Whurr R, Clarke CE, Playford D, Ben-Shlomo Y. A comparison of speech and language therapy techniques for patients with Parkinson s disease. Cochrane Database Syst Rev 2001;2: CD Deane KH, Whurr R, Clarke CE, Playford D, Ben-Shlomo Y. Non-pharmacological therapies for dysphagia in Parkinson s disease. Cochrane Database Syst Rev 2001;1:CD Bridgewater KJ, Sharpe MH. Trunk muscle training and early Parkinson s disease. Physiother Theor Pract 1997;13: Wells MR, Giantinoto S, D Agate D, et al. Standard osteopathic manipulative treatment acutely improves gait performance in patients with Parkinson s disease. J Am Osteopath Assoc 1999;99: Cerri C, Arosio A, Biella AM, Premoselli S, Piccini L. Physical exercise therapy of Parkinson s. Mov Disord 1994;9(Suppl. 1): Chandler C, Plant R. A targeted physiotherapy service for people with Parkinson s disease from diagnosis to end stage: a pilot study. In: Percival R, Hobson P, editors. Parkinson s disease: studies in psychological and social care. Leicester: BPS Books; p Comella CL, Stebbins GT, Brown-Toms N, Goetz CG. Physical therapy and Parkinson s disease: a controlled clinical trial. Neurology 1994;44: Forkink A, Toole T, Hirsch MA, Lehman DA, Maitland CG. The effects of a balance and strengthening program on equilibrium in Parkinsonism. Tallahassee: Florida State University; Toole T, Hirsch MA, Forkink A, Lehman DA, Maitland CG. The effects of a balance and strength training program on equilibrium in Parkinsonism: a preliminary study. Neurorehabilitation 2000; 14: Gibberd FB, Page NGR, Spencer KM, Kinnear E, Williams JB. A controlled trial of physiotherapy for Parkinson s disease. In: Rose FC, Capildeo R, editors. Recent progress in Parkinson s disease. Tunbridge Wells: Pitman Medical; p Gibberd FB, Page NGR, Spencer KM, Kinnear E, Hawksworth JB. Controlled trial of physiotherapy and occupational therapy for Parkinson s disease. Br Med J 1981;282: Homann CN, Crevenna R, Kojnig H, et al. Can physiotherapy improve axial symptoms in parkinsonian patients? A pilot study with the computerized movement analysis battery Zebris. Mov Disord 1998;13(Suppl. 2): Hurwitz A. The benefit of a home exercise regimen for ambulatory Parkinson s disease patients. J Neurosci Nurs 1989;21: Katsikitis M, Pilowsky I. A controlled study of facial mobility treatment in Parkinson s disease. J Psychosom Res 1996;40: Patti F, Reggio A, Nicoletti F, Sellaroli T, Deinite G, Nicoletti F. Effects of rehabilitation therapy on parkinsonians disability and functional independence. J Neurol Rehabil 1996;10: Schenkman M, Cutson TM, Kuchibhatla M, et al. Exercise to improve spinal flexibility and function for people with Parkinson s disease: a randomised controlled trial. J Am Geriatr Soc 1998;46: Thaut MH, McIntosh GC, Rice RR, Miller RA, Rathbun J, Brault JM. Rhythmic auditory stimulation in gait training for Parkinson s disease patients. Mov Disord 1996;11: Marchese R, Diverio M, Zucchi F, Lentino C, Abbruzzese G. Comparison of two physical therapy approaches in the rehabilitation of parkinsonian patients: a comparison of two physical therapy protocols. Mov Disord 2000;15: Hirsch MA. Activity dependent enhancement of balance following strength and balance training [doctoral thesis]. Florida State University; Muller V, Mohr B, Rosin R, Pulvermuller F, Muller F, Birbaumer N. Short-term effects of behavioural treatment on movement initiation and postural control in Parkinson s disease: A controlled clinical study. Mov Disord 1997;12: Mohr B, Muller V, Mattes R, et al. Behavioural treatment of Parkinson s disease leads to improvement of motor skills and to tremor reduction. Behav Ther 1996;27: Palmer SS, Mortimer JA, Webster DD, Bistevins R, Dickinson GL. Exercise therapy for Parkinson s disease. Arch Phys Med Rehabil 1986;67: Shiba Y, Obuchi S, Toshima H, Yamakita H. Comparison between visual and auditory stimulation in gait training of patients with idiopathic Parkinson s disease. World Congress of Physical Therapy Conference, Yokohama, Japan; Fiorani C, Mari F, Bartolini M, Ceravolo M, Provinciali L. Occupational therapy increases ADL score and quality of life in Parkinson s disease. Mov Disord 1997;12(Suppl. 1): Gauthier L, Dalziel S, Gauthier S. The benefits of group occupational therapy for patients with Parkinson s disease. Am J Occup Ther 1987;41: Johnson JA, Pring TR. Speech therapy and Parkinson s disease: a review and further data. Br J Disord Commun 1990;25: Ramig LO, Sapir S, Fox C, Countryman S. Changes in vocal loudness following intensive voice treatment (LSVT) in individuals with Parkinson s disease: a comparison with untreated patients and normal age-matched controls. Mov Disord 2001;16: Robertson SJ, Thomson F. Speech therapy in Parkinson s disease: a study of the efficacy and long term effects of intensive treatment. Br J Disord Commun 1984;19:

8 REVIEW OF PARAMEDICAL THERAPIES FOR PD Ramig LO, Countryman S, Thompson LL, Horii Y. Comparison of two forms of intensive speech treatment for Parkinson s disease. J Speech Hear Res 1995;38: Ramig LO, Countryman S, O Brien C, Hoehn M, Thompson L. Intensive speech treatment for patients with Parkinson s disease: short- and long-term comparison of two techniques. Neurology 1996;47: Ramig LO, Dromey C. Aerodynamic mechanisms underlying treatment-related changes in vocal intensity in patients with Parkinson s disease. J Speech Hear Res 1996;39: Ramig L, Hoyt P, Seeley E, Sapir S. Voice treatment (LSVT) for IPD: Perceptual findings. Parkinsonism Relat Disord 1999;5(Suppl.):S Ramig LO, Sapir S, Countryman S, et al. Intensive voice treatment (LSVT) for individuals with Parkinson s disease: a two-year follow-up. J Neurol Neurosurg Psychiatry 2001;71: Smith ME, Ramig LO, Dromey C, Perez KS, Samandari R. Intensive voice treatment in Parkinson s disease: laryngostroboscopic findings. J Voice 1995;9: Scott S, Caird FI. Speech therapy for Parkinson s disease. J Neurol Neurosurg Psychiatry 1983;46: Scott S, Caird FI, Williams BO. The effect of speech therapy on communication. In: Scott S, Caird FI, Williams BO, editors. Communication in Parkinson s disease. Beckenham, Kent: Croom Helm; p GPDS. The Global Parkinson s Disease Survey. An insight into quality of life with Parkinson s disease. London: The Parkinson s Disease Society of the UK; Dysarthria. In: van der Gaag A, Reid D, editors. Clinical guidelines by consensus for speech and language therapists. London: Royal College of Speech and Language Therapists; p Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. J Am Med Assoc 1996;276: Palmer SS, Mortimer JA, Webster DD, Bistevins R, Dickinson GL. Comparison of stretch exercises and karate training as therapy for Parkinson s disease. Arch Phys Med Rehabil 1984;65: Baumgartner CA, Sapir S, Ramig LO. Perceptual voice quality changes following phonatory-respiratory effort treatment (LSVT) vs. respiratory effort treatment for individuals with Parkinson s disease. J Voice 2001 (in press). 52. Gibb WRG, Lees AJ. The relevance of the Lewy body to the pathogenesis of idiopathic Parkinson s disease. J Neurol Neurosurg Psychiatry 1988;51: APPENDIX. Criteria for quality assessment Quality item Randomisation method Concealment of allocation Cointerventions constant (e.g. drug therapy) Placebo therapy Withdrawals described & <10% of original population Blinded assessors Missing values present for <10% of original population Intention-to-treat data analysis Between-group statistical data comparison Definition Adequate: Truly random methods such as use of random number tables. Inadequate: Quasi-random methods such as alternate allocation. Adequate: The allocation of patients into a group was concealed in a manner impervious to any influence by the individual making the allocation e.g. by having allocation in sealed, opaque sequentially numbered envelopes. Inadequate: The allocation is unconcealed e.g. list of random numbers was posted on bulletin board. Adequate: Medication was kept constant during the therapy. Changes in medication were allowed during the follow-up period. Inadequate: No attempt was made to keep drugs constant. Adequate: Participants were treated with an inactive form of therapy for a similar period of time and in a similar location to the active therapy group. Inadequate: Untreated or treated for a lesser period of time or in a significantly different setting. Adequate: Reasons for all withdrawals provided. Total number of withdrawals less than 10% of the original population. Inadequate: Reasons not given and number withdrawn is greater than 10% of the original population. Adequate: Assessors prevented from knowing allocation of participants. Inadequate: Assessors aware of participant allocation. Adequate: Missing values due to incomplete assessment or withdrawals are less than 10% of the original population. Inadequate: Missing values are greater than 10% of the original population. Adequate: Data analysed on the basis of randomised allocation irrespective of protocol deviations. Missing data substituted by using last observation carried forward. Inadequate: Data analysed on a per protocol basis, according to actual treatment received and ignoring withdrawals. Adequate: Appropriate statistical tests used to compare data between the two treatment groups, either the data at the end time point or the change in the data over the duration of the trial. Inadequate: Inappropriate statistical methods used or the groups not compared statistically one with the other.