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

Not Applicable

Completed

• Conditions: Stroke Rehabilitation
• Interventions: Other: Unilateral Task-specific Training; Other: Robotic-assisted Therapy with Bilateral Practice; Other: Sensorimotor Stimulation Program

• Registration Number: NCT03847103
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-15
• Primary Completion: 2017-03-02
• Study Completion: 2017-03-02
• Status Verified: 2019-02
• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral task-specific training	Unilateral Task-specific Training	In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
Robotic-aided rehabilitation with bilateral practice	Robotic-assisted Therapy 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.
Unilateral task-specific training	Sensorimotor Stimulation Program	In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
Robotic-aided rehabilitation with bilateral practice	Sensorimotor Stimulation Program	In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs.

Primary Outcome Measures

Name	Time	Method
Change in the result of Motor Activity Log	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 Outcome Measures

Name	Time	Method
Change in the result of Fugl-Meyer assessment for UE motor function	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.
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	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.

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan