Home Based Adaptive Arm Training for Children With Hemiplegia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Study Overview
Brief Summary
Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks.
The specific aims of this proposal are to:
Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home training program.
Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following ABI.
It is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acquired Brain Injury at least 3 months prior to enrollment.
- •Unilateral hemiparesis
- •History of compliance with home exercise programs in the past.
Exclusion Criteria
- •Any social or medical problem that precludes compliance with the protocol
- •Comorbid seizure disorder or other neurological disease
- •Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment
- •Implanted neuromodulatory or electronic device or other complicating illness
- •Lack of capacity to consent
Arms & Interventions
Bimanual-to-unimanual device home training program
Intervention: m2 Bimanual Arm Trainer (BAT) (Device)
Conventional non-device home training program
Subjects receive 6 weeks of ongoing usual and customary care schedule of home physical and occupational therapy as usual and customary care independent of the study.
Outcomes
Primary Outcomes
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Time Frame: 6 Weeks
Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
Time Frame: 6 Weeks
Measure of impairments in motor functioning and recovery in children post hemiplegia.
Secondary Outcomes
No secondary outcomes reported