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1 Copyright 2016 EDIZIONI Spasticity is defined as a velocity-dependent increase in muscle tone characterized by hyperactive stretch reflex following upper motor neuron injury. 1, 2 In stroke rehabilitation, spasticity has been an important topic due to its high incidence up to 65% and close relationship with impaired motor function. 3-9 In particular, spasticity of the wrist and hand is a serious disabling and troublesome problem for stroke patients. 10, 11 Therefore, proper and active management of spasticity of the wrist and hand is necessary for successful stroke rehabilitation in terms of spasticity itself and motor function. ORIGINAL ARTICLE European Journal of Physical and Rehabilitation Medicine 2016 February;52 (1):65-71 The effect of a wrist-hand stretching device for spasticity in chronic hemiparetic stroke patients Woo H. 1, Hyuk C. KWON 2, Kyong J. YOO 1, Sung H. 1 * 1Department of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University, Yeungnam, Republic of Korea; 2Department of Occupational Therapy, College of Rehabilitation Science, Daegu University, Daegu, Republic of Korea *Corresponding author: Sung H. Jang, Department of Physical Medicine and Rehabilitation, College of Medicine, Yeungnam University 317-1, Daemyungdong, Namku, Daegu, , Republic of Korea. strokerehab@hanmail.net ABSTRACT BACKGROUND: The majority of these stretching devices have focused on spasticity of the leg and only a few devices have been developed for spasticity of the wrist and hand. In addition, most of these devices were large and complicated, with less easy applicability for personal use. Aim: To investigate the effect of a stretching device for spasticity of the wrist and hand in chronic hemiparetic stroke patients. Design: Prospective single blind randomized controlled clinical trial. Setting: Outpatients. Methods: Patients were randomly assigned to either the intervention group (11 patients) or the control group (10 patients). The stretching device consisted of a circular shaped plastic plate and five holders to immobilize the fingers. In position 1, finger tips were facing forward, position 2 was 90 external rotation from position 1, and position 3 was 90 external rotation from position 2. Each position was maintained for 4 minutes and a rest period of 1 minute was given, therefore, one session was performed for 14 minutes. The stretching program was conducted 3 sessions/day, 6 days/week for 4 weeks. Spasticity (modified Ashworth scale [MAS]) and motor function (Fugl-Meyer motor assessment [FMA], Active Range of Motion [AROM]) of affected wrist and hand were assessed three times (first assessment; Pre, second assessment; post-2 weeks, third assessment; post-4 weeks). RESULTS: In the intervention group, significant differences in the wrist and hand MAS and FMA were observed between three assessment times (P<0.05). However, no significant differences in the wrist and hand AROM were observed between three assessment times (P>0.05). In the control group, no differences in MAS, FMA, and AROM were observed between three assessment times (P>0.05). Conclusion: Findings showed that this stretching device was effective in terms of relieving spasticity and functional recovery. Clinical REHABILITATION IMPACT: This stretching device is effective in spasticity reducing and motor function improvement. Moreover, it is useful to patient because it is easy to use and portable. (Cite this article as: Jang WH, Kwon HC, Yoo KJ, Jang SH et al. The effect of a wrist-hand stretching device for spasticity in chronic hemiparetic stroke patients. Eur J Phis Rehabil Med 2016;52:65-71) Key words: Muscle Stretching Exercises - Equipment and Supplies - Muscle Spasticity - Stroke - Wrist. Among the many, that have been developed for control of spasticity in stroke patients, stretching exercise has been used as a basic modality for a long time in the rehabilitation field because of easy availability, fewer side effects, and cost-effectiveness Based on clinical application of the stretching exercise, many stretching devices have been developed However, the majority of these stretching devices have focused on spasticity of the leg and only a few devices have been developed for spasticity of the wrist and hand In addition, most of these devices were large and com- Vol No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 65

2 Clinical evaluations of spasticity and function Spasticity and motor function of affected wrist and hand were assessed three times for 4 weeks in our hospital. The first assessment was performed before starting the stretching program, the second and third assessments were performed at 2 weeks and 4 weeks after starting the stretching program, respectively (first assessment; pre, second assessment; post-2 weeks, third assessment; post-4 weeks). The MAS was used for evaluation of the severity of spasticity in the flexor muscles of wrist and five metacarpophalangeal (MCP) joints: 0 (no increase in muscle tone); 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension; 1 + (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 (more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3 (considerable increase in muscle tone, passive movement difficult); 4 (affected part(s) rigid in flexion or extension). 33 Categories 1 + to 4 of the MAS were modified to 2 to 5 for statistical analysis. Fugl-Meyer Motor Assessment (FMA) Scores and Active Range of Motion (AROM) were used for evaluplicated, with less easy applicability for personal use. Therefore, we believe that the development of a simple and easily applicable stretching device for spasticity of the wrist and hand would be useful and necessary for stroke patients with severe spasticity. In the current study, we investigated the effect of a stretching device for spasticity of the wrist and hand in chronic hemiparetic stroke patients. Subjects Materials and methods Twenty-one consecutive stroke patients (17 males, 4 females; mean, 49.1±13.5 years; range, 32 to 68 years, 17 intracranial hemorrhages and 4 cerebral infarcts) were recruited according to the following criteria: 1) age: years; 2) more than 6 months after stroke onset; 3) incomplete weakness of the affected wrist and finger extensor to the extent of an inability to move without gravity (Medical Research Council grade: <2); 4) severe spasticity of the affected wrist and finger flexors (modified Ashworth Scale (MAS) Score 2); ) no contracture of the affected wrist or fingers; 6) no history of peripheral nerve injury or musculoskeletal disease (e.g., arthritis, musculotendinous injury or bone fracture) in the affected upper extremity; and 7) no history of any invasive procedure (Botox, alcohol, or phenol) for treatment of spasticity for at least 6 months before the start of this study. Patients with apraxia, somatosensory problems, or cognitive problems (Mini-Mental State Examination Score of <24) were excluded. All patients were randomly assigned to either the intervention group (11 patients; 10 males; mean age, 48.8±14.8 years) or the control group (10 patients; 7 males; mean age, 49.5±14.2 years). We did not change any drugs or perform any procedures that might affect spasticity during the study period. All patients provided written informed consent and the study protocol was approved by our Institutional Review Board. Stretching device The stretching device consisted of a circular shaped plastic plate and five holders to immobilize the fingers. The back side of the stretching device was attached to rubber to prevent slippage (Figure 1A). Stretching protocol The patient placed the affected hand on the plate and inserted five fingers into the holders, respectively, and fastened the holders by Velcro straps (Figure 1A). Every stretching exercise was performed in weight bearing position using the stretching device (Figure 1B); In position 1, finger tips were facing forward, position 2 was 90 external rotation from position 1, position 3 was 90 external rotation from position 2 (Figure 2A). Each position was maintained for 4 minutes and a resting period of 1 minute was given between each position, therefore, one session was performed for 14 minutes. Stretching program was conducted 3 sessions/ day, 6 days (Monday to Saturday) per week for 4 weeks in their own home or office. We provided the patients in the intervention group with a checklist and instructed them to use the checklist after every session of the stretching program. There was no training program for the control group. 66 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE February 2016

3 Figure 1. A) Stretching device: the stretching device consists of a circular shaped plastic plate and five holders to immobilize the fingers. Back side of the stretching device is attached to rubber to prevent slippage. The patient places the affected hand on the plate and inserts five fingers into the holders, respectively, and fastens the holders by Velcro straps (B) stretching protocol: every stretch is performed in weight bearing position using a stretching device. In position 1, finger tips are facing forward, position 2 is 90 external rotation from position 1, and position 3 is 90 external rotation from position 2. A C E A B Figure 2. Serial changes of clinical assessment. (A) Modified Ashworth Scale (MAS) Score in wrist flexor muscle; (B) MAS Score in hand (metacarpophalangeal joint, MCP joint) flexor muscle; (C) Fugl Meyer Assessment (FMA) Score in wrist; (D) FMA Score in hand; (E) Active Range Of Motion (AROM) Score in wrist; (F) AROM Score in hand. 1st; pre assessment, 2nd; post-2 weeks assessment, 3rd; post-4 weeks assessment. * P<0.05. Vol No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 67 B D F

4 Table I. Demographic and baseline clinical data of patients. Intervention group ation of motor function. 7, 34 The wrist and hand subsection of the FMA, consisting of 12 tasks scored using a 3-point ordinal scale (0 to 2; maximum score of 24), was used to evaluate motor function in affected hands. AROM was measured in degrees using a manual goniometer by asking participants to extend their affected wrist and MCP joints maximally starting from a fully flexed state while they were seated with their forearm restrained in a neutral position in order to reduce the effect of gravity. Clinical evaluation was performed by a physician who was blinded to the group of the patient. Statistical analysis SPSS software (v.17.0; SPSS, Chicago, IL, USA) was used for the data analysis. Demographic factors of patients and the MAS, FMA, and AROM at baseline (Pre/1st) were compared between the intervention group and the control group in order to determine whether the recruitment and group assignment of patients were homogeneous or not, using the Mann-Whitney U Test due to the small number of patients. However, the χ 2 test was used for sex, affected side, and type of stroke. We used the two way repeated measures Analysis Of Variance (ANOVA) Test to determine effect analysis according to assessment time between groups. One statistical sphericity (P>0.05) and one multivariate test (P<0.05) was used. Post-hoc analyses using the Bonferroni correction were performed for assessment of differences between pre, post-2 weeks, and post-4 weeks. The significant level of the P-value was set at Sex (M:F) 10:1 7:3 17: Age (yrs) 48.8 (14.8) 49.5 (14.2) 49.1 (13.5) Type (ICH:Infarct) 9:2 8:2 17: Affected side (R:L) 5:6 6:4 11: Duration (days) 2217 (1280) 1900 (1119) 2054 (1218) Baseline MAS Wrist 1.72 (0.79) 1.90 (0.88) 1.81 (0.81) Hand 2.00 (1.06) 1.60 (0.66) 1.81 (0.91) FMA Wrist 2.81 (2.52) 4.40 (2.76) 3.57 (2.70) Hand 5.55 (4.61) 8.10 (5.04) 6.76 (4.88) AROM Wrist 100 (52.72) (56.88) (64.86) Hand (57.46) (47.73) (51.94) Values indicate mean (standard deviation). ICH: intracranial hemorrhage; duration: duration from onset to the first clinical assessment; baseline: the first clinical assessment time (1st/Pre), MAS: Modified Ashworth Scale Score; FMA: Fugl-Meyer Assessment; AROM: active range of motion. Results No significant differences in the demographic data and baseline clinical data (MAS, FMA, and AROM) were observed between the intervention group and the control group (P>0.05) (Table I). The two-way repeated measures ANOVA test for evaluation of the effect of intervention across all time points between the two groups showed a significant interaction between time and effect of intervention in the wrist MAS, hand MAS, wrist FMA, and hand FMA (P<0.05). No significant differences in the wrist and hand AROMs were observed between the two groups (P>0.05). In the intervention group, significant differences in the wrist MAS were observed between pre (1.72) and post-2 weeks (0.91), between pre (1.72) and post-4 weeks (0.82) (P<0.05). In the hand MAS, significant differences were also observed between three assessment times (pre; 2.00), (post-2 weeks; 1.36), (post-4 weeks; 0.90) (P<0.05). Significant differences in wrist FMA were observed between three assessment times (pre; 2.82), (post-2 weeks; 4.00), (post-4 weeks; 4.63) (P<0.05). In the hand FMA, we observed significant difference between three assessment times (pre; 5.55), (post-2 weeks; 6.18, (post-4 weeks; 6.90) (P<0.05). In the wrist and hand AROMs, mean values were increased with time, however, no significant differences were observed (P>0.05). In the control group, no differences in MAS, FMA, and AROM were observed between three assessment times (P>0.05) (Table II, Figure 2). 68 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE February 2016 Control group Total P

5 Table II. Clinical data according to the assessment time in the intervention and control groups. Evaluation Group 1st/pre 2nd/post-2 weeks 3rd/post-4 weeks MAS(Wrist) * Study 1.72 (0.79) a 0.91 (0.54) 0.82 (0.40) b Control 1.90 (0.87) 1.80 (0.63) 1.80 (0.63) MAS(Hand) * Study 2.00(1.10) a 1.36 (0.71) b 0.90 (0.44) c Control 1.60 (0.66) 1.55 (0.69) 1.25 (0.65) FMA(Wrist) * Study 2.82 (2.52) c 4.00 (2.68) b 4.63 (2.62) a Control 4.40 (2.76) 4.40 (2.76) 4.40 (2.76) FMA(Hand) * Study 5.55 (4.61) c 6.18 (4.67) b 6.90 (4.82) a Control 8.10 (5.04) 8.10 (5.04) 8.10 (5.04) AROM(Wrist) Study (72.08) (56.81) (53.73) Control (56.88) (57.50) (57.59) AROM(Hand) Study (57.46) (60.17) (61.20) Control (47.72) (47.72) (50.14) Values indicate mean (standard deviation). The effect of intervention across all time points between the two groups ( * P<0.05). Different letters ( a, b, c ) indicate statistically significant difference verified by the Bonferroni collection (P<0.05). Discussion In this study, we investigated the effect of a static stretching device on spasticity and motor function of the wrist and hand for four weeks in chronic hemiparetic stroke patients. Our results were as follows: first, in the intervention group, the wrist and hand MAS decreased over four weeks whereas no significant change was observed in the control group; second, the wrist and hand FMAs showed improvement over four weeks, although no significant change was observed in the control group. Third, in terms of the wrist and hand AROM, we did not observe significant changes in both the intervention and control groups, although mean values were increased with time in the intervention group. Because MAS, FMA, and AROM mean the degree of spasticity, functional state, and motor state, respectively, our results indicate that in the intervention group, the spasticity and functional state were improved whereas motor state did not show significant change. In other words, by using our stretching device for four weeks, the hemiparetic stroke patients achieved relief of spasticity and functional recovery of the wrist and hand without significant motor recovery. In addition, we confirmed that the compliance and safety of this stretching device were good because all subjects completed the stretching program without any problems. Many studies have reported on the effect of stretching exercise on reducing spasticity. 15, 30, 31, 35, 36 Therefore, many devices for reducing spasticity using stretching exercise have been developed; however, the majority of these devices were for relieving spasticity of lower ex- Vol No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 69 tremity such as hip, knee, or ankle Compared with the number of stretching devices for lower extremity spasticity, fewer stretching devices for hand and wrist spasticity have been developed , 28, 29 In 2011, Brokaw et al. developed a stretching device that assists the extension of the spastic hand using a series of elastic cords in stroke patients. They found that the stretching device was effective in improvement of range of motion (finger extension) and hand function (block lifting). 28 During the same year, Triandafilou et al. compared the effect of prolonged stretching and repetitive stretching using powered glove orthosis in chronic stroke patients and found that repetitive stretching was more effective than prolonged stretching in terms of hand function after 1 session (30 minutes) respectively. 29 The above two studies have investigated the immediate effect without a long-term training. 28, 29 By contrast, regarding the studies on the effect of long-term stretching program using a stretching device, in 2011, Jung et al. developed a stretching device that was designed to stretch the affected wrist and hand using pulleys and conducted a stretching program (1 session [20 minutes]: repeated stretching [30 seconds] and relaxation [30 seconds], 2 sessions/day and 6 days/week) for 3 weeks for stroke patients with severe hand weakness and spasticity. 16 They found that the spasticity of the affected hand was reduced. In 2013, the same research group upgraded the above mentioned stretching device and conducted the stretching program (1 session [10 minutes]: maintain stretching, 2 sessions/day and 7 days/week) for 4 weeks. 17, 18 They found that the spasticity of the affected hand was reduced in patients with complete hand

6 11. Pundik S, Falchook AD, McCabe J, Litinas K, Daly JJ. Functional Brain Correlates of Upper Limb Spasticity and Its Mitigation following Rehabilitation in Chronic Stroke Survivors. Stroke Res Treat 2014;2014: Gracies JM. Pathophysiology of impairment in patients with spasticity and use of stretch as a treatment of spastic hypertonia. Phys Med Rehabil Clin N Am 2001;12:747-68, vi. 13. Stokes M. Physical management of neurological rehabilitation. Second edition. London: Elsevier Mosby; Pin T, Dyke P, Chan M. The effectiveness of passive stretching in children with cerebral palsy. Dev Med Child Neurol 2006;48: Tsai KH, Yeh CY, Chang HY, Chen JJ. Effects of a single session of prolonged muscle stretch on spastic muscle of stroke patients. Proc Natl Sci Counc Repub China B 2001;25: Jung YJ, Hong JH, Kwon HG, Song JC, Kim C, Park S, et al. The effect of a stretching device on hand spasticity in chronic hemiparetic stroke patients. NeuroRehabilitation 2011;29: Jo HM, Song JC, Jang SH. Improvements in spasticity and motor function using a static stretching device for people with chronic hemiparesis following stroke. NeuroRehabilitation 2013;32: Kim EH, Chang MC, Seo JP, Jang SH, Song JC, Jo HM. The effect of a hand-stretching device during the management of spasticity in chronic hemiparetic stroke patients. Ann Rehabil Med 2013;37: Starring DT, Gossman MR, Nicholson GG Jr, Lemons J. Comparison of cyclic and sustained passive stretching using a mechanical device to increase resting length of hamstring muscles. Phys Ther 1988;68: Yeh CY, Chen JJ, Tsai KH. Quantifying the effectiveness of the sustained muscle stretching treatments in stroke patients with ankle hypertonia. J Electromyogr Kinesiol 2007;17: Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol, Avon) 2011;26: Zhang LQ, Chung SG, Bai Z, Xu D, van Rey EM, Rogers MW, et al. Intelligent stretching of ankle joints with contracture/spasticity. IEEE Trans Neural Syst Rehabil Eng 2002;10: Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedbackcontrolled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil 2005;86: Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair 2011;25: Wu CL, Huang MH, Lee CL, Liu CW, Lin LJ, Chen CH. Effect on spasticity after performance of dynamic-repeated-passive ankle joint motion exercise in chronic stroke patients. Kaohsiung J Med Sci 2006;22: Bohannon RW. Device for stretching spastic hip adductor muscles. Suggestion from the field. Phys Ther 1983;63: Yeh CY, Tsai KH, Chen JJ. Effects of prolonged muscle stretching with constant torque or constant angle on hypertonic calf muscles. Arch Phys Med Rehabil 2005;86: Brokaw EB, Black I, Holley RJ, Lum PS. Hand Spring Operated Movement Enhancer (HandSOME): a portable, passive hand exoskeleton for stroke rehabilitation. IEEE Trans Neural Syst Rehabil Eng 2011;19: Triandafilou KM, Ochoa J, Kang X, Fischer HC, Stoykov ME, Kamper DG. Transient impact of prolonged versus repetitive stretch on hand motor control in chronic stroke. Top Stroke Rehabil 2011;18: Nuyens GE, De Weerdt WJ, Spaepen AJ Jr, Kiekens C, Feys HM. Reduction of spastic hypertonia during repeated passive knee movements in stroke patients. Arch Phys Med Rehabil 2002;83: Harvey LA, Batty J, Crosbie J, Poulter S, Herbert RD. A randomized trial assessing the effects of 4 weeks of daily stretching on ankle moweakness and severe spasticity, and the spasticity and motor function of the affected hand and wrist improved in stroke patients with incomplete hand weakness and severe spasticity, respectively. 17, 18 However, the above mentioned stretching devices were not easy to use and uncomfortable to carry due to large size. By contrast, we believe that the stretching device used in this study is smaller and easier to use and carry by a patient. Conclusions In conclusion, we investigated the effect of a static stretching device for spasticity of the wrist and hand for four weeks in chronic hemiparetic stroke patients, and found that this stretching device was effective in terms of relieving spasticity and functional recovery. This result would be important in spasticity control and helpful to other patients with severe spasticity as well as stroke patients with spasticity. 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7 bility in patients with spinal cord injuries. Arch Phys Med Rehabil 2000;81: Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987;67: Kaya T, Karatepe AG, Gunaydin R, Koc A, Altundal Ercan U. Interrater reliability of the Modified Ashworth Scale and modified Modified Ashworth Scale in assessing poststroke elbow flexor spasticity. Int J Rehabil Res 2011;34: Vol No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE Pedretti LW. Occupational therapy: practice skills for physical dysfunction. St. Louis: Mosby; Carey JR. Manual stretch: effect on finger movement control and force control in stroke subjects with spastic extrinsic finger flexor muscles. Arch Phys Med Rehabil 1990;71: Bressel E, McNair PJ. The effect of prolonged static and cyclic stretching on ankle joint stiffness, torque relaxation, and gait in people with stroke. Phys Ther 2002;82: Funding. This research was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education, Science and Technology (2012R1A1A4A ). Conflicts of interest. The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Article first published online: June 18, Manuscript accepted: June 17, Manuscript revised: March 2, Manuscript received: December 18, 2015.