Robot-assisted Hand Rehabilitation for Patients With Stroke

NCT03392493 | Completed

• 1 other identifier: TMU-JIRB N201704068
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Robotic rehabilitation; Hand function; Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment：Upper Limb section

  Upper Limb motor function

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

Secondary Outcomes (6)

• 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

• Dynanometer

  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

• Revision of the Nottingham Sensory Assessment

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

Study Arms (2)

Group A

EXPERIMENTAL

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; Behavioral: Standard treatment

Group B

ACTIVE COMPARATOR

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; Behavioral: Standard treatment

Interventions

Robot-assisted hand rehabilitation BEHAVIORAL

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.

Group A; Group B

Standard treatment BEHAVIORAL

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.

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

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

Taipei, Taiwan

Location

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jui chi Lin, master

  Taipei Medical University, Taiwan, R.O.C.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: AB or BA

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: January 8, 2018
• Study Start: February 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 3, 2018

Record last verified: 2018-06

Locations

TW (1)