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

Stroke Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847103
• Other study ID #: B-ER-102-247
• Status: Completed
• Phase: N/A
• Start date: April 15, 2014
• Est. completion date: March 2, 2017

Study information

• Verified date: February 2019
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the result of Fugl-Meyer assessment for UE motor function	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
Secondary	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	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