Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Taipei, Taiwan
NCT Number: NCT03392493
Robotic therapy can deliver larger amounts of upper extremity movement practice for stroke rehabilitation. Although the treatment effects were supported in studies, there are still limitations in clinical intervention. The study will use the robot-assisted hand rehabilitation with a Gloreha device. Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA), Modified Barthel Index. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
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Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Taipei, Taiwan
Many stroke survivors suffered problems with the upper extremity, such as paresis, synergy movement, hypertonicity, jag movement, sensory deficit. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg,work, driving). For individuals with more severe paresis, the potential for recovery of upper extremity function is greatly reduced. Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility compared with dose-matched conventional upper limb exercise therapies. Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on sensory, motor, and ADL ability for patients with stroke.
Materials and Methods: Thirty patients with moderate motor deficits were recruited and randomized into 2 treatment groups, AB or BA (A = 12 times of robot-assisted hand rehabilitation, B = 12 times of standard therapy) for 12 weeks of treatment (Sixty minutes a time, twice a week), 1 month of break between conditions for washout period. The performance was assessed by a blinded assessor for five times (pre-test1, post-test 1, pre-test2, post-test 2, follow up at three month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Abductor pollicis brevis(APB), Flexor digitorum(FD), Dynanometer, Semmes-Weinstein hand monofilament (SWM), Revision of the Nottingham Sensory Assessment (EmNSA) for hand evaluations, Modified Barthel Index for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at 0.05. The hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on sensory, motor, hand function, and ADL ability among patients with stroke.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Robot-assisted hand rehabilitation: 20 minute of worm-up exercise and 40 minute of robot-assisted hand exercise. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task and robot-assisted task.
Standard treatment only group: 60 min standard treatment. 20 minute of worm-up exercise and 40 minute of traditional occupational therapy. Traditional occupational therapy include spasticity-reducing activity, bilateral hands activity and hand training task.
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Upper Limb motor function
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Upper Limb motor function
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Grip strength
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Grip strength
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Light touch
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Proprioception
Time frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Activity of daily live ability
Taipei Medical University Shuang Ho Hospital
Other
The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
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