Evaluation of a Wearable Exoskeleton for Functional Arm Training
NCT ID: NCT02726204
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2015-06-01
2016-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Gravity Elimination Alone
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
Path Assistance Alone
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
Path Assistance and Gravity Elimination
Chronic Post Stroke Right Side Hemiparesis
Radiologically verified unilateral stroke patients with at least 4 months previously.
Gravity Elimination Alone
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
Path Assistance Alone
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
Path Assistance and Gravity Elimination
Interventions
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Gravity Elimination Alone
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
Path Assistance Alone
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
Path Assistance and Gravity Elimination
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Preeti Raghavan, MD
Role: PRINCIPAL_INVESTIGATOR
New York University Medical School
Locations
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New York University School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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15-00402
Identifier Type: -
Identifier Source: org_study_id