Clinical trial NCT03847103: Robotic-assisted Therapy With Bilateral Practice Improves Task and Motor Performance of the Upper Extremity for Chronic Stroke Patients
Official title: Effects of Robotic-aided Therapy Combined With Bilateral Arm Training on Motor Performance and Electrophysiological Parameters of Upper Extremity for the Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: Stroke
Robotic-Assisted Therapy
Bilateral Practice
Task-specific Training
Rehabilitation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the result of Motor Activity Log
timeFrame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Secondary outcomes:
measure: Change in the result of Fugl-Meyer assessment for UE motor function
timeFrame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
measure: 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
timeFrame: Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
citation: Hsu HY, Chiu HY, Kuan TS, Tsai CL, Su FC, Kuo LC. Robotic-assisted therapy with bilateral practice improves task and motor performance in the upper extremities of chronic stroke patients: A randomised controlled trial. Aust Occup Ther J. 2019 Oct;66(5):637-647. doi: 10.1111/1440-1630.12602. Epub 2019 Jul 17.