Back to resultsRobotic-assisted Therapy With Bilateral Practice Improves Task and Motor Performance of the Upper Extremity for Chronic Stroke Patients
Primary Purpose
Stroke Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Robotic-assisted Therapy with Bilateral Practice
Unilateral Task-specific Training
Sensorimotor Stimulation Program
Sponsored by
About this trial
This is an interventional treatment trial for Stroke Rehabilitation focused on measuring Stroke, Robotic-Assisted Therapy, Bilateral Practice, Task-specific Training, Rehabilitation
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
Sites / Locations
- National Cheng-Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Robotic-aided rehabilitation with bilateral practice
Unilateral task-specific training
Arm Description
In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs.
In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03847103
First Posted
February 12, 2019
Last Updated
February 27, 2019
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03847103
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2014 (Actual)
Primary Completion Date
March 2, 2017 (Actual)
Study Completion Date
March 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Stroke, Robotic-Assisted Therapy, Bilateral Practice, Task-specific Training, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic-aided rehabilitation with bilateral practice
Arm Type
Experimental
Arm Description
In addition to a 10-minutes sensorimotor stimulation programs, the experimental group received 40-minutes Robotic-assisted Therapy with Bilateral Practice programs.
Arm Title
Unilateral task-specific training
Arm Type
Active Comparator
Arm Description
In addition to a 10-minutes sensorimotor stimulation programs, the control subjects received 40-minute unilateral task-specific training.
Intervention Type
Other
Intervention Name(s)
Robotic-assisted Therapy with Bilateral Practice
Intervention Description
40-minute robotic-assisted therapy with bilateral practice program for wrist and forearm repetitive movement training was performed during each session.
Intervention Type
Other
Intervention Name(s)
Unilateral Task-specific Training
Intervention Description
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
Intervention Name(s)
Sensorimotor Stimulation Program
Intervention Description
10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach
Primary Outcome Measure Information:
Title
Change in the result of Motor Activity Log
Description
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.
Time Frame
Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Secondary Outcome Measure Information:
Title
Change in the result of Fugl-Meyer assessment for UE motor function
Description
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.
Time Frame
Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
Title
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
Description
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.
Time Frame
Baseline, endpoint (4 weeks) and follow-up (16 weeks) assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31317553
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.
Results Reference
derived
Learn more about this trial
Robotic-assisted Therapy With Bilateral Practice Improves Task and Motor Performance of the Upper Extremity for Chronic Stroke Patients
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