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

NCT03847103 | Completed

• 1 other identifier: B-ER-102-247
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Rehabilitation

Keywords

Stroke; Robotic-Assisted Therapy; Bilateral Practice; Task-specific Training; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in the result of Motor Activity Log

  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 Outcomes (2)

• 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 Arms (2)

Robotic-aided rehabilitation with bilateral practice

EXPERIMENTAL

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; Other: Sensorimotor Stimulation Program

Unilateral task-specific training

ACTIVE COMPARATOR

In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.

Other: Unilateral Task-specific Training; Other: Sensorimotor Stimulation Program

Interventions

Robotic-assisted Therapy with Bilateral Practice OTHER

40-minute robotic-assisted therapy with bilateral practice program for wrist and forearm repetitive movement training was performed during each session.

Robotic-aided rehabilitation with bilateral practice

Unilateral Task-specific Training OTHER

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.

Unilateral task-specific training

Sensorimotor Stimulation Program OTHER

10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach

Robotic-aided rehabilitation with bilateral practice; Unilateral task-specific training

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31317553 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 20, 2019
• Study Start: April 15, 2014
• Primary Completion: March 2, 2017
• Study Completion: March 2, 2017
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

TW (1)