Clinical trial NCT02749500: Early Independent Adaptive Arm and Hand Rehab
Official title: Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Hemiparesis
Keywords: Motor control
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Performance tasks of the Fugl-Meyer Scale (FMS)
timeFrame: 12 Weeks
measure: Upper extremity functional ability measured with Modified Rankin Scale
timeFrame: 12 Weeks
measure: Stroke-related quality of life measured with the Stroke Impact Scale
timeFrame: 12 Weeks
measure: Spasticity measured using the Modified Ashworth Scale
timeFrame: 12 Weeks
measure: Range of motion will be measured using video
timeFrame: 12 Weeks
measure: Upper extremity functional ability measured using the Wolf Motor Function Test
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Maria Tafurt, MD
role: PRINCIPAL_INVESTIGATOR
References: