Evaluation of a Wearable Exoskeleton for Functional Arm Training

Stroke Clinical Trial

Official title:

Evaluation of a Wearable Exoskeleton for Functional Arm Training (CAREX)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726204
• Other study ID #: 15-00402
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: May 5, 2016

Study information

• Verified date: December 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 5, 2016
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paresis
• Post-Stroke Hemiparesis
• Stroke

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive range of motion measured by goniometry		1 Day
Primary	Active range of motion measured by goniometry		1 Day
Primary	Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)		1 Day
Primary	Spasticity measured by the Modified Ashworth Scale (MAS)		1 Day