Early Independent Adaptive Arm and Hand Rehab

NCT ID: NCT02749500

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-01-19

Brief Summary

The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.

Detailed Description

This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Conditions

Post-stroke Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Occupational Therapy (OT)

Standard of care occupational therapy for stroke recovery

Group Type: ACTIVE_COMPARATOR

Conventional Occupational Therapy (OT)

Intervention Type: OTHER

Standard of care occupational therapy for stroke recovery

OT + Device-assisted therapy

Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. The m2 BAT will enable repeated movement of the affected body part without the help of a therapist, providing the opportunity to maintain range-of motion in the affected limb to limit spasticity, contracture and the ensuing deformity, a major goal of rehabilitation therapy and produces movement in the affected limb from activating the patient's own brain, rather than from being acted on by an external powered source such as a robot.

Group Type: EXPERIMENTAL

Conventional Occupational Therapy (OT)

Intervention Type: OTHER

Standard of care occupational therapy for stroke recovery

m2 BAT

Intervention Type: DEVICE

Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Interventions

Conventional Occupational Therapy (OT)

Standard of care occupational therapy for stroke recovery

Intervention Type: OTHER

m2 BAT

Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Ability to follow study instructions
• Ability to likely complete all required visits
• Ability to comply with the therapy protocol as assessed by the investigator
• Must be English speaking
• Subjects must have had a unilateral stroke

Exclusion Criteria

• 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.
• 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.
• 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.
• Patients who are cognitively impaired.
• Patients who lack capacity to consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Tafurt, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

15-01460

Identifier Type: -

Identifier Source: org_study_id