Early Independent Adaptive Arm and Hand Rehab

Study Overview
=================
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.

Official Title
-----------------
Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke

Conditions
-----------------
Post-stroke Hemiparesis

Intervention / Treatment
-----------------
* Other: Conventional Occupational Therapy (OT)
* Device: m2 BAT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor control