Early Independent Adaptive Arm and Hand Rehab

NCT02749500 | Completed

• 1 other identifier: 15-01460
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Hemiparesis

Keywords

Motor control

Outcome Measures

Primary Outcomes (6)

• Performance tasks of the Fugl-Meyer Scale (FMS)

  This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.

  12 Weeks

• Upper extremity functional ability measured with Modified Rankin Scale

  12 Weeks

• Stroke-related quality of life measured with the Stroke Impact Scale

  12 Weeks

• Spasticity measured using the Modified Ashworth Scale

  12 Weeks

• Range of motion will be measured using video

  Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.

  12 Weeks

• Upper extremity functional ability measured using the Wolf Motor Function Test

  12 Weeks

Study Arms (2)

Conventional Occupational Therapy (OT)

ACTIVE COMPARATOR

Standard of care occupational therapy for stroke recovery

Other: Conventional Occupational Therapy (OT)

OT + Device-assisted therapy

EXPERIMENTAL

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.

Other: Conventional Occupational Therapy (OT); Device: m2 BAT

Interventions

Conventional Occupational Therapy (OT) OTHER

Standard of care occupational therapy for stroke recovery

Conventional Occupational Therapy (OT); OT + Device-assisted therapy

m2 BAT DEVICE

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

OT + Device-assisted therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Study Officials

• Maria Tafurt, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 25, 2016
• Study Start: June 1, 2017
• Primary Completion: January 19, 2018
• Study Completion: January 19, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)