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Clinical Trials/NCT03392493
NCT03392493
Completed
Not Applicable

The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke

Taipei Medical University Shuang Ho Hospital1 site in 1 country25 target enrollmentFebruary 1, 2018
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
25
Locations
1
Primary Endpoint
Fugl-Meyer Assessment:Upper Limb section
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
June 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Fugl-Meyer Assessment:Upper Limb section

Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month

Upper Limb motor function

Secondary Outcomes

  • Revision of the Nottingham Sensory Assessment(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
  • Dynanometer(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
  • Box and block test(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
  • 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)
  • Semmes-Weinstein hand monofilament(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)
  • Modified barthel index(Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month)

Study Sites (1)

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