KINEMATIC GAIT ANALYSIS

Transcription

1 KINEMATIC GAIT ANALYSIS June 2007 Department of Medical and Surgical Procedures Assessment

2 THE TEAM This report was compiled by Dr Françoise Saint-Pierre, project manager in the Department of Medical and Surgical Procedures Assessment. Documentary research was conducted by Ms. Christine Devaud, documentation officer, and Ms. Renée Cardoso, assistant documentation officer, under the guidance of Dr Frédérique Pagès, head of the documentation unit. The meeting and secretarial services were organised by Félix Muller Contact details regarding this dossier: Tel.: +33 (0) Fax: +33 (0) Department of Medical and Surgical Procedures Assessment Head of Department: Dr Sun Hae Lee-Robin Assistant Head of Department: Dr Denis-Jean David - 2 -

3 SUMMARY INTRODUCTION - The request for an assessment of the procedure "kinematic gait analysis was made by UNCAM [French state health insurance body] and SOFMER (Société française de médecine physique et de réadaptation) [French society of physical medicine and rehabilitation] with a view to including it on the list of procedures covered by health insurance. - The Haute Autorité de Santé has assessed the expected benefits of this procedure in order to form an opinion as to whether it should be added to this list. CONTEXT - Medical context: The kinematic gait parameters describe the movements involved in various spatial planes, without investigating the forces that lie behind the movements. Consequently, a kinematic gait analysis evaluates the trajectories of the various parts of the body, their movement, their angles and the way in which they change over time, as well as linear and angular speeds and accelerations. Various systems of measurement exist, ranging in cost and complexity. Accelerometers can measure simple gait parameters, such as the duration and symmetry of running step and walking speed. Recording accelerations at trunk level provides general information about the variability or steadiness of walking. Goniometry is the process of taking direct measurements of joint angles and the way in which they alter during movement. The advantage of goniometers is that they allow an important element of a movement to be easily measured, especially if it is a large movement such as flexion-extension of the knee. Investigation of complex movements involving translation movements requires a more delicate approach, using other optoelectronic systems. These have the advantage of not impeding movement in any way. They also provide more complete data in all three directions: sagittal (angulation of the pelvis, flexion-extension angle of the hips, knees and ankles), frontal (oscillation of the pelvis, abduction-adduction angle of the hips) and horizontal (rotation of the pelvis, rotation of the parts of the legs). Many different neurological, orthopaedic and rheumatological pathologies can cause gait disorders, as well as various types of malformation. 13.4% of the population (over 8 million people) suffers from some form of moderate or slight motor deficiency, usually associated with rheumatism or arthrosis. Motor deficiency affects 1% of young children, over half of people in their eighties and two-thirds of people in their nineties. The resulting disabilities can restrict the individual's activity and reduce his or her mobility. - Nomenclatures: The procedure is not listed in the Common Classification of Medical Procedures tariff schedule. It has been identified in the American nomenclature

4 ASSESSMENT The method proposed by HAS for assessing the expected clinical benefit of medical or surgical procedures is based on the scientific data found in the literature and on the opinion of a working group of healthcare professionals. Critical analysis of literature data Publications examined The literature from 2000 to February 2007 was surveyed through a search of the principal medical literature databases (Medline, The Cochrane Library, National guideline clearinghouse and HTA Database). Two hundred and ninety-five documents were obtained, 30 quoted, of which 14 were analysed. The articles meeting the following criteria were selected and analysed: - 13 studies assessing the technical performance of various measurement devices: 10 reproducibility studies, one reliability study and two comparative studies (different systems of analysis); - five studies assessing the expected benefits in terms of treatment efficacy and performance. Indications Analysis of movements (pelvis, hips, knees and ankles) in gait disorders caused by neurological, orthopaedic or rheumatological factors or by malformation in two contexts: 1 - Help in therapeutic decision-making (surgery, aids, drugs, rehabilitation programme); 2 - Assessment of treatment efficacy. Efficacy - Studies conducted on accelerometers (number of patients: n = 112) show that they allow for satisfactory reproducible analysis ( ) of simple gait parameters such as walking and running step length, duration and symmetry of stride, and walking speed. Angular kinematic measurements of joints and orientations of the lower limbs are correlated (0.98) with other 3D systems of analysis, but the measurements obtained with the ambulatory systems investigated relate only to sagittal measurements in two dimensions. - Studies conducted on goniometers (n = 201) show that they allow for satisfactory assessment of the degree of mobility of the knee and ankle joints. Intra-observer reproducibility of the parameters is good; it is higher for major flexions. Inter-investigator reproducibility is less satisfactory. Measurements must be taken by the same examiner using the same goniometer to achieve optimum analytical results. - Most of the studies we found that were conducted on 3D movement analysis systems were evaluation studies (n = 87) underlining the expected benefits of the technique by providing more comprehensive information on the gait kinematics (identifying compensation strategies involving certain joints in hemiplegic gait disorders) and therefore enabling the practitioner to choose the optimum therapy. These systems also allow practitioners to assess the efficacy of treatments (surgery, drugs, orthotic devices) and adjust the treatment if necessary

5 Safety The bibliography does not identify any complications associated with the procedures. Role within the diagnostic and therapeutic strategy As a complement to a clinical examination, it allows practitioners to analyse the kinematic gait parameters: the trajectories of the various parts of the body, their movement, their angles and the way in which they change over time, as well as linear and angular speeds and accelerations. In this way it provides objective data which can be used in considering therapeutic approaches and evaluating the efficacy of treatments. Conditions of use A physical medicine and rehabilitation reference guide describes how movement analysis should be performed. Impact on the general population, health care system and public health programmes No study of the impact on public health was identified. Position of the working group Indications This examination is indicated for the analysis of movements and angular variations in walking disorders caused by neurological, orthopaedic or rheumatological (inflammatory rheumatism) factors or by malformation. Treatment strategy/alternative techniques Kinematic analysis is a complement to a thorough clinical examination. Simple devices or goniometers can be used to assess a particular problem or function. These portable systems allow patients to be examined outside the laboratory, which is not the case for a 3D analysis. However, these tools are becoming more technically sophisticated all the time, producing 2D and 3D images. They always assess the patient's performance under actual conditions. Efficacy The working group accepts the reproducibility and efficacy criteria described in the dossier. However, it emphasises that various instruments and systems are available, with different levels of sophistication that are reflected in their price. Safety There is some risk of falling; therefore patients must be examined in appropriate conditions. Training required To effectively carry out this examination, either basic training in physical medicine and rehabilitation as part of the third cycle of an undergraduate medicine course, or additional training leading to a specific inter-university diploma. The group emphasises that interpreting the results requires at least as much skill as performing the procedure. Environment required The group agrees with the environment described in the reference guide available in physical medicine and rehabilitation practices. It points out the need for high-quality work in the light of the assessment of professional practices (APP)

6 Estimated target population The examination is necessary because of the severity of the pathology. It is difficult to determine how many of these procedures are carried out in France as no set tariff has been established for them. Experts believe there is a gap between the population currently benefiting from this procedure and the population that stands to benefit. It is difficult to calculate how many centres there are in France. Two centres per regional department would be a reasonable assumption. In a previous dossier on (metrological) gait analysis, the number of procedures was assessed at around 500 per centre per year, giving a total of 95,000. The group stresses that this figure covered all analyses of walking and included the three types of analysis: metrological, baropodometric and kinematic, each of which produce different data depending on the information being sought. Conclusions of the working group The group agreed to approve listing of the procedure with a sufficient expected benefit (EB). Target population Data from the literature So many pathologies exist, at varying degrees of severity that it is impossible to produce an accurate estimate of the number of patients affected by the procedures. Data provided by professionals The examination is necessary because of the severity of the pathology. In a previous dossier on (metrological) gait analysis, the number of procedures was assessed at around 500 per centre per year, giving a total of 95,000. The group stresses that this figure covered all gait analyses and included the three types of analysis: metrological, baropodometric and kinematic, each of which produce different data depending on the information being sought. CONCLUSION Therapeutic benefit Kinematic gait analysis is the only way of analysing movements and angular variations in gait disorders caused by neurological, orthopaedic or rheumatological (inflammatory rheumatism) factors or by malformation. This evaluation is vital in order to help practitioners decide on the best therapy and to assess the efficacy of treatments. Public health benefit No study of the impact on public health was identified. The disabilities caused by the handicap take the form of pain, restricted activity, reduced mobility leading to difficulties at work, loss of autonomy and risk of falling. In the light of this data, the expected benefit is regarded as sufficient. The improvement in the expected benefit is regarded as minor (IV), because of: - the usefulness of the procedure as a second-line option to quantify dysfunctionality, to help in determining therapy and in order to objectively assess the efficacy of treatments; - the severity of the pathologies under examination