- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575481
Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
June 28, 2018 updated by: Hadassah Medical Organization
Differences in Muscle Activity and Fatigue of the Upper Limb Between Task-Specific Training and Robot Assisted Training Among Individuals Post Stroke
The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.
Study Overview
Detailed Description
Twenty sub-acute post stroke subjects received one TST and one RAT.
They marked the pain level in their paretic extremity before and after each session.
Muscle activity levels and fatigue and number of repetitions were monitored during each session.
The subjective assessment questionnaire of treatment and the Borg scale were administered post-session.
Study Type
Observational
Enrollment (Actual)
20
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
-
-
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Jerusalem, Israel, 91240
- Hadassah Medical Center
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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
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
stroke survivors
Description
Inclusion Criteria:
- 18 to 85 year old individuals up to three months following stroke
- National Institutes of Health Stroke Scale (NIHSS) score 3-15
- Intact cognitive function
- mild to moderate weakness of the affected hand
- normal or corrected eyesight
Exclusion Criteria:
- neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function
- a pace-maker
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Post stroke patients
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The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle activity
Time Frame: 30 minutes
|
The activity levels of electromyographic signal (in millivolts) will be averaged for the duration of the recording.
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30 minutes
|
Muscle fatigue
Time Frame: 30 minutes
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Fatigue expressed by calculation of the the difference between the median frequency in the first 5 minutes and last five minutes of a 30 minute session
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30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
September 30, 2015
Primary Completion (ACTUAL)
March 1, 2017
Study Completion (ACTUAL)
March 29, 2017
Study Registration Dates
First Submitted
June 17, 2018
First Submitted That Met QC Criteria
June 28, 2018
First Posted (ACTUAL)
July 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 28, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0295-15-HMO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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