Early Independent Adaptive Arm and Hand Rehab

Recruitment & Eligibility

Inclusion Criteria

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 & Design

Arm && Interventions

Group	Intervention	Description
OT + Device-assisted therapy	Conventional Occupational Therapy (OT)	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.
Conventional Occupational Therapy (OT)	Conventional Occupational Therapy (OT)	Standard of care occupational therapy for stroke recovery
OT + Device-assisted therapy	m2 BAT	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.

Primary Outcome Measures

Name	Time	Method
Upper extremity functional ability measured with Modified Rankin Scale	12 Weeks
Range of motion will be measured using video	12 Weeks	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.
Performance tasks of the Fugl-Meyer Scale (FMS)	12 Weeks	This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.
Stroke-related quality of life measured with the Stroke Impact Scale	12 Weeks
Spasticity measured using the Modified Ashworth Scale	12 Weeks
Upper extremity functional ability measured using the Wolf Motor Function Test	12 Weeks

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility