- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03624153
The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients
May 13, 2021 updated by: Chang Gung Memorial Hospital
The Effects of the EMG-driven Exoskeleton Hand Robotic Training Device on Upper Extremity Motor and Physiological Function, Daily Functions, Quality of Life and Self-efficacy in Brain Injury Patients
The purpose of this study is to examine the effects of the EMG-driven exoskeleton hand robotic training device on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in brain injury patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study was to 1) examine the effects of EMG-driven robot-assisted intervention, and 2) examine whether the robot-assisted therapy is as effective as conventional intervention.
The study was conducted using a randomized, two-period crossover design.
Participants were randomly assigned to group 1 or group 2 using a computer-generated list.
Participants in group 1 received 12 sessions of robot-assisted intervention first, followed by a one-month washout period, and then received 12 sessions of conventional intervention.
Participants in group 2 received 12 sessions of conventional intervention first, followed by a one-month washout period, and then received 12 sessions of robot-assisted intervention.
Outcome measures were performed before the intervention, after the first 12-session intervention, and after the second 12-session intervention.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- unilateral stroke ≥ 3 months prior to study enrollment
- Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score <60
- without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3)
- Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment
- between the ages of 20 and 75 years.
Exclusion criteria:
- histories of other neurological diseases such as dementia and peripheral polyneuropathy
- difficulties in following and understanding instructions such as global aphasia
- enroll in other rehabilitation or drug studies simultaneously
- receiving Botulinum toxin injections within 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Robotic-assisted intervention
70 minutes Robotic-assisted intervention.
|
Participants received the 12-session robot-assisted intervention 3 sessions a week for 4 consecutive weeks.
Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.
|
ACTIVE_COMPARATOR: Conventional intervention
70 minutes conventional rehabilitation.
|
Participants received the 12-session conventional rehabilitation intervention 3 sessions a week for 4 consecutive weeks.
The intervention consisted of warm up including range of motion exercise, and strengthening exercise followed by task-oriented training for activities of daily living.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change scores of Fugl-Myer Assessment (FMA)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke.
The UE-FMA contains 33 movements with a score range from 0 to 66.
A higher UE-FMA score indicates less impairment of the paretic limb.
The validity and reliability of FMA is good to excellent.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of Wolf Motor Function Test (WMFT)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The WMFT is a reliable method to evaluate the UE motor ability in patients after stroke.
The WMFT contains 15 function-based tasks and 2 strength-based tasks.
The time (WMFT-time) and the functional ability (WMFT-quality) for an individual to complete the tasks will be recorded.
A shorter WMFT-time and a larger WMFT-quality score indicate a faster movement and better quality of movement, respectively.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of Motor Activity Log (MAL)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The MAL will be used to assess the amount of use (AOU) and quality of movement (QOM) of the paretic UE.
The MAL is a semi-structured interview that tests object manipulation and gross motor activities of daily living.
The psychometric properties of MAL have been well-established, and a higher MAL score indicates better movement quality.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of Action Research Arm Test (ARAT)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The Action Research Arm Test (ARAT) evaluates 19 tests of arm motor function, both distally and proximally.
Each test is given an ordinal score of 0, 1, 2, or 3, with higher values indicating better arm motor status.
The total ARAT score is the sum of the 19 tests, and thus the maximum score is 57.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change scores of Mini-Mental State Exam (MMSE)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning.
The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function.
The total score of MMSE ranged from 0 to 30.
Higher values represent a better cognitive functioning.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of Jamar hand dynamometer
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated.
Excellent concurrent validity of the Jamar hand dynamometer is reported.
The Jamar hand dynamometer measure the grip-strength.
The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb.
Higher value represent a greater grip-strength.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of stroke self-efficacy questionnaire (SSEQ)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
the Stroke Self-Efficacy Questionnaire (SSEQ) , a questionnaire developed to measure the most relevant self-efficacy and self-management domains specific to the stroke population.
It contains 13 items that are rated on a 0 - 10 scale, with higher scores indicating greater levels of self-efficacy.
Questionnaire includes a range of relevant functional tasks such as walking, getting comfortable in bed, as well as some self-management tasks.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of Modified Ashworth Scale (MAS)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions.
Higher score indicates higher muscle tone.
Investigators will assess the MAS scores of UE muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors.
The validity and reliability of MAS for patients with stroke were established to be adequate to good.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Change scores of Active Range of Motion (AROM)
Time Frame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Patient performs the exercise to move the joint without any assistance to the muscles surrounding the joint.
|
Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ching-Yi Wu, Chang Gung University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 30, 2018
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
August 7, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (ACTUAL)
August 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 13, 2021
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201701543B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Stroke
-
The University of Texas Health Science Center,...Recruiting
-
National Yang Ming UniversityCompleted
-
IRCCS San Raffaele RomaIRCCS Sacro Cuore Don Calabria di Negrar; Ospedale Riabilitativo di Alta Specializzazione... and other collaboratorsCompletedCardiovascular Diseases | Vascular Diseases | Cerebrovascular Disorders | Brain Diseases | Central Nervous System Diseases | Acute Stroke | Chronic Stroke | Severe Stroke | Mild StrokeItaly
-
University of Illinois at ChicagoNot yet recruiting
-
VA Office of Research and DevelopmentRecruitingChronic StrokeUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Chronic Stroke | Subacute StrokeThailand
-
University of WashingtonRecruitingStroke, Ischemic | Chronic StrokeUnited States
-
Ever Neuro Pharma GmbHVASCage GmbHTerminatedChronic Stroke | Subacute StrokeAustria
-
IRCCS San Raffaele RomaAzienda Ospedaliero, Universitaria Pisana; I.R.C.C.S. Fondazione Santa Lucia; Fondazione Don Carlo Gnocchi Onlus and other collaboratorsCompletedStroke | Acute Stroke | Chronic StrokeItaly
Clinical Trials on Robotic-assisted intervention
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
Corindus Inc.CompletedMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Vascular Diseases | Coronary Artery Disease | Coronary Disease | Arteriosclerosis | Arterial Occlusive DiseasesUnited States, Israel
-
Hospital Israelita Albert EinsteinUnknownCoronary Artery Disease
-
Corindus Inc.CompletedPeripheral Arterial DiseaseAustria
-
Auris Health, Inc.CompletedLung Cancer | Pulmonary NoduleUnited States, Canada, China
-
Fondazione Don Carlo Gnocchi OnlusNot yet recruiting
-
Fondazione Don Carlo Gnocchi OnlusCompleted
-
St. Joseph's Healthcare HamiltonUnknown
-
Intuitive SurgicalActive, not recruitingThymoma | Myasthenia Gravis | Primary Lung Cancer | Benign Lung DiseaseUnited States