Post-stroke Hemiparesis
Conditions
Keywords
Motor control
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.
Interventions
Standard of care occupational therapy for stroke recovery
DEVICEm2 BAT
Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | 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. |
| Upper extremity functional ability measured using the Wolf Motor Function Test | 12 Weeks | — |
Countries
United States
Outcome results
None listed