- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726204
Evaluation of a Wearable Exoskeleton for Functional Arm Training
December 21, 2018 updated by: NYU Langone Health
Evaluation of a Wearable Exoskeleton for Functional Arm Training (CAREX)
The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke.
This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
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
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria for stroke population:
- Radiologically verified unilateral stroke at least 4 months previously.
- Right-handed subjects with or without right hemiparesis (as robot is built for right arm alone).
- Preserved passive range of motion at all upper limb joints.
- Spasticity <3 on the modified Ashworth Scale (MAS).
- Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.
Exclusion Criteria for stroke population.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke ( as we are recruiting subjects with first unilateral stroke), epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
Inclusion Criteria for control population.
- No previous stroke or any other previous neurological injury.
- Right-handed subjects without any weakness or hemiparesis (as robot is built for right arm alone).
- Preserved passive and active range of motion at all upper limb joints.
- No increase in muscle tone in response to passive range of motion. A score of zero on Ashworth Scale (MAS).
- Able to achieve full score on upper extremity Fugl-Meyer Scale (66/66)
- Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.
Exclusion Criteria for control population.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Subjects
Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
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CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
CAREX will push subject's arm to a pre-specified path.
If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path.
The subject will feel like having a spring connected between his hand and the path
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Active Comparator: Chronic Post Stroke Right Side Hemiparesis
Radiologically verified unilateral stroke patients with at least 4 months previously.
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CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
CAREX will push subject's arm to a pre-specified path.
If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path.
The subject will feel like having a spring connected between his hand and the path
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Passive range of motion measured by goniometry
Time Frame: 1 Day
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1 Day
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Active range of motion measured by goniometry
Time Frame: 1 Day
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1 Day
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Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)
Time Frame: 1 Day
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1 Day
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Spasticity measured by the Modified Ashworth Scale (MAS)
Time Frame: 1 Day
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1 Day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Preeti Raghavan, MD, New York University Medical School
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)
June 1, 2015
Primary Completion (Actual)
May 5, 2016
Study Completion (Actual)
May 5, 2016
Study Registration Dates
First Submitted
March 17, 2016
First Submitted That Met QC Criteria
March 28, 2016
First Posted (Estimate)
April 1, 2016
Study Record Updates
Last Update Posted (Actual)
December 24, 2018
Last Update Submitted That Met QC Criteria
December 21, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-00402
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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