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Clinical Trials/NCT03847103
NCT03847103
Completed
Not Applicable

Effects of Robotic-aided Therapy Combined With Bilateral Arm Training on Motor Performance and Electrophysiological Parameters of Upper Extremity for the Stroke Patients

National Cheng-Kung University Hospital1 site in 1 country43 target enrollmentApril 15, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke Rehabilitation
Sponsor
National Cheng-Kung University Hospital
Enrollment
43
Locations
1
Primary Endpoint
Change in the result of Motor Activity Log
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Task-specific repetitive training, an usual care in occupational therapy practice, and robotic-aided rehabilitation with bilateral practice to improve limb's movement control has been popularised; however the difference in treatment effects between this two therapeutic strategies has been rarely described. The aim of the study was to compare the efficacy of robotic-assisted therapy with bilateral practice (RTBP) and usual care on task and motor performance for chronic stroke patients.

Registry
clinicaltrials.gov
Start Date
April 15, 2014
End Date
March 2, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • chronic stroke patients with unilateral cerebral infarction or hemorrhage and whose disease duration was more than six months following stroke
  • no evidence of any other cerebral pathology in study screening CT scan
  • a score for the Fugl-Meyer upper extremity motor assessment ranging from 23-53 corresponding to poor to notable arm-hand capacity
  • pre stroke ability to speak the Chinese
  • without any other possible somatic sensory impairment, no major cognitive-perceptual deficit based on the results of selective neuropsychological tests, such as the mini-mental state examination (MMSE) and Lowenstein occupational therapy cognitive assessment (LOTCA)
  • premorbid right-handedness

Exclusion Criteria

  • less than six months following stroke
  • CT shows multiple cerebral infarction or hemorrhage
  • whose comprehension skills were insufficient to understand instructions
  • individuals whose score of MMSE was lower than 24 or sub-item scores of visual perception, spatial perception, praxis, and visuomotor organization in LOTCA was lower than 8, 6, 6, and 14, respectively
  • premorbid left-handedness

Outcomes

Primary Outcomes

Change in the result of Motor Activity Log

Time Frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments

Motor activity log is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.

Secondary Outcomes

  • Change in the result of Fugl-Meyer assessment for UE motor function(Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments)
  • Change in root mean square (RMS) value and the median frequency of the power spectrum of each detected motor unit action potential during maximum voluntary contraction(Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments)

Study Sites (1)

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