Robotic-assisted Therapy With Bilateral Practice Improves Task and Motor Performance of the Upper Extremity for Chronic Stroke Patients

February 27, 2019 updated by: National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng-Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Robotic-aided rehabilitation with bilateral practice
In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs.
Other: Robotic-assisted Therapy with Bilateral Practice
40-minute robotic-assisted therapy with bilateral practice program for wrist and forearm repetitive movement training was performed during each session.
Other: Sensorimotor Stimulation Program
10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach
ACTIVE_COMPARATOR: Unilateral task-specific training
In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
Other: Sensorimotor Stimulation Program
10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach
Other: Unilateral Task-specific Training
40 -minute unilateral task-specific training using various tasks: picks up beans with spoon, pouring water from one glass to another glass, opening and closing a drawer, drinking from a mug, and wiping the table were chosen for facilitating multitude of upper extremity functions. Three tasks per session were chosen for various specific components of hand-arm function training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the result of Fugl-Meyer assessment for UE motor function
Time Frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
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
Time Frame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Power and frequency function of Surface Electromyogram signals are reliable parameter to evaluate motor behavior of stroke survivors. The location sEMG electrodes were placed on the muscle belly of the anterior deltoid, flexor carpi radialis and extensor carpi radialis of the affected forearm.
Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2014

Primary Completion (ACTUAL)

March 2, 2017

Study Completion (ACTUAL)

March 2, 2017

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (ACTUAL)

February 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ER-102-247

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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