Early Independent Adaptive Arm and Hand Rehab

Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Hemiparesis
• Intervention / Treatment: Other: Conventional Occupational Therapy (OT); Device: m2 BAT

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Occupational Therapy (OT); Standard of care occupational therapy for stroke recovery	Other: Conventional Occupational Therapy (OT); Standard of care occupational therapy for stroke recovery
Experimental: 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.	Other: Conventional Occupational Therapy (OT); Standard of care occupational therapy for stroke recovery; Device: m2 BAT; Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Maria Tafurt, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 19, 2018
• Study Completion (Actual): January 19, 2019

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Motor control
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 15-01460

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No