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Robot-assisted Hand Rehabilitation for Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Robot-assisted hand rehabilitation
Standard treatment
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Robotic rehabilitation, Hand function, Activities of Daily Living

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment:Upper Limb section
Upper Limb motor function

Secondary Outcome Measures

Box and block test
Upper Limb motor function
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus
Grip strength
Dynanometer
Grip strength
Semmes-Weinstein hand monofilament
Light touch
Revision of the Nottingham Sensory Assessment
Proprioception
Modified barthel index
Activity of daily live ability

Full Information

First Posted
August 24, 2017
Last Updated
November 29, 2018
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03392493
Brief Title
Robot-assisted Hand Rehabilitation for Patients With Stroke
Official Title
The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Robotic rehabilitation, Hand function, Activities of Daily Living

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
AB or BA
Masking
Outcomes Assessor
Masking Description
Single Blind (Outcomes Assessor)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Robot-assisted hand rehabilitation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment:Upper Limb section
Description
Upper Limb motor function
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Secondary Outcome Measure Information:
Title
Box and block test
Description
Upper Limb motor function
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Title
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi, abductor pollicis longus
Description
Grip strength
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Title
Dynanometer
Description
Grip strength
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Title
Semmes-Weinstein hand monofilament
Description
Light touch
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Title
Revision of the Nottingham Sensory Assessment
Description
Proprioception
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month
Title
Modified barthel index
Description
Activity of daily live ability
Time Frame
Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jui chi Lin, master
Organizational Affiliation
Taipei Medical University, Taiwan, R.O.C.
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Robot-assisted Hand Rehabilitation for Patients With Stroke

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