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Robot-assisted Hand Rehabilitation for Patients With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392493
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

Tracking Information
First Submitted Date  ICMJE August 24, 2017
First Posted Date  ICMJE January 8, 2018
Last Update Posted Date December 3, 2018
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2018)
  • Box and block test [ Time Frame: 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 [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Grip strength
  • Dynanometer [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Grip strength
  • Semmes-Weinstein hand monofilament [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Light touch
  • Revision of the Nottingham Sensory Assessment [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Proprioception
  • Modified barthel index [ Time Frame: Change from baseline to 6 weeks, 10 weeks,16weeks, follow up at three month ]
    Activity of daily live ability
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot-assisted Hand Rehabilitation for Patients With Stroke
Official Title  ICMJE The Effects on Hand Function With Robot-assisted Rehabilitation for Patients With Stroke
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
AB or BA
Masking: Single (Outcomes Assessor)
Masking Description:
Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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)
    Interventions:
    • Behavioral: Robot-assisted hand rehabilitation
    • Behavioral: Standard treatment
  • 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)
    Interventions:
    • Behavioral: Robot-assisted hand rehabilitation
    • Behavioral: Standard treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 2, 2018)
30
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03392493
Other Study ID Numbers  ICMJE TMU-JIRB N201704068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Taipei Medical University Shuang Ho Hospital
Study Sponsor  ICMJE Taipei Medical University Shuang Ho Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jui chi Lin, master Taipei Medical University, Taiwan, R.O.C.
PRS Account Taipei Medical University Shuang Ho Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP