Evaluation of a Wearable Exoskeleton for Functional Arm Training

NCT02726204 | Completed

• 1 other identifier: 15-00402
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Post-Stroke Hemiparesis

Outcome Measures

Primary Outcomes (4)

• Passive range of motion measured by goniometry

  1 Day

• Active range of motion measured by goniometry

  1 Day

• Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)

  1 Day

• Spasticity measured by the Modified Ashworth Scale (MAS)

  1 Day

Study Arms (2)

Healthy Subjects

ACTIVE COMPARATOR

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.

Other: Gravity Elimination Alone; Other: Path Assistance Alone; Other: Path Assistance and Gravity Elimination

Chronic Post Stroke Right Side Hemiparesis

ACTIVE COMPARATOR

Radiologically verified unilateral stroke patients with at least 4 months previously.

Other: Gravity Elimination Alone; Other: Path Assistance Alone; Other: Path Assistance and Gravity Elimination

Interventions

Gravity Elimination Alone OTHER

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

Chronic Post Stroke Right Side Hemiparesis; Healthy Subjects

Path Assistance Alone OTHER

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

Chronic Post Stroke Right Side Hemiparesis; Healthy Subjects

Path Assistance and Gravity Elimination OTHER

Chronic Post Stroke Right Side Hemiparesis; Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Preeti Raghavan, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: April 1, 2016
• Study Start: June 1, 2015
• Primary Completion: May 5, 2016
• Study Completion: May 5, 2016
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

US (1)