Early Independent Adaptive Arm and Hand Rehab

NYU Langone Health

Status: Completed

Conditions: Post-stroke Hemiparesis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02749500

15-01460

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

Conventional Occupational Therapy (OT)

Active Comparator group

Description:

Standard of care occupational therapy for stroke recovery

Treatment:

Other: Conventional Occupational Therapy (OT)

OT + Device-assisted therapy

Experimental group

Description:

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.

Treatment:

Device: m2 BAT

Other: Conventional Occupational Therapy (OT)