Robot-assisted Hand Rehabilitation for Patients With Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: Robot-assisted hand rehabilitationBehavioral: Standard treatment
- Registration Number
- NCT03392493
- Lead Sponsor
- Taipei Medical University Shuang Ho Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- First stroke with hemiplegia
- Chronicity > 3 months
- Could understand the instructions
- Brunnstrom stageⅡ-Ⅴ
- Sensory impairment (Revision of the Nottingham Sensory Assessment-Tatile< 2; Kinaesthetic < 3)
- Modified Ashworth Scale < 3
- Age younger than 20 and older than75 years
- Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
- Individuals with other medical symptoms that can affect movement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A Standard treatment In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week) Group B Robot-assisted hand rehabilitation In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week) Group A Robot-assisted hand rehabilitation In the phase 1 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week); In the phase 2 :12 training sessions of Standard treatment only. (60 minutes a time, 2 times a week) Group B Standard treatment In the phase 1 :12 training sessions of Standard treatment only(60 minutes a time, 2 times a week) ; In the phase 2 :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week)
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment：Upper Limb section Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Upper Limb motor function
- Secondary Outcome Measures
Name Time Method Revision of the Nottingham Sensory Assessment Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Proprioception
Dynanometer Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Grip strength
Box and block test Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Upper Limb motor function
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Grip strength
Semmes-Weinstein hand monofilament Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Light touch
Modified barthel index Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month Activity of daily live ability
Trial Locations
- Locations (1)
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
🇨🇳Taipei, Taiwan