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

NCT ID: NCT03847103

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-15
• Study Completion Date: 2017-03-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Robotic-assisted Therapy with Bilateral Practice

Intervention Type: OTHER

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

Sensorimotor Stimulation Program

Intervention Type: OTHER

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

Unilateral task-specific training

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

Group Type: ACTIVE_COMPARATOR

Unilateral Task-specific Training

Intervention Type: 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.

Sensorimotor Stimulation Program

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Sensorimotor Stimulation Program

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cheng-Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 31317553 (View on PubMed)

Other Identifiers

B-ER-102-247

Identifier Type: -

Identifier Source: org_study_id