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Robot-assisted Hand Rehabilitation for Patients With Stroke

Sponsor
Taipei Medical University Shuang Ho Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03392493
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
4.9
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Robot-assisted hand rehabilitation
  • Behavioral: Standard treatment
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
AB or BAAB or BA
Masking:
Single (Outcomes Assessor)
Masking Description:
Single Blind (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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)

Behavioral: Robot-assisted hand rehabilitation
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.

Behavioral: Standard treatment
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.
Active Comparator: Group B

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)

Behavioral: Robot-assisted hand rehabilitation
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.

Behavioral: Standard treatment
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Box and block test [Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month]

    Upper Limb motor function

  2. 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

  3. Dynanometer [Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month]

    Grip strength

  4. Semmes-Weinstein hand monofilament [Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month]

    Light touch

  5. Revision of the Nottingham Sensory Assessment [Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month]

    Proprioception

  6. Modified barthel index [Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month]

    Activity of daily live ability

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University Taipei Taiwan

Sponsors and Collaborators

  • Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Chair: Jui chi Lin, master, Taipei Medical University, Taiwan, R.O.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier:
NCT03392493
Other Study ID Numbers:
  • TMU-JIRB N201704068
First Posted:
Jan 8, 2018
Last Update Posted:
Dec 3, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Medical University Shuang Ho Hospital
Stroke
Robotic rehabilitation
Hand function
Activities of Daily Living
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Dec 3, 2018