Home Based Adaptive Arm Training for Children

Study Overview
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Brief Summary
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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.

Official Title
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Home Based Adaptive Arm Training for Children With Hemiplegia

Conditions
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Hemiplegia

Intervention / Treatment
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* Device: m2 Bimanual Arm Trainer (BAT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimanual-to-unimanual device home training program<br> | Device: m2 Bimanual Arm Trainer (BAT)<br>* Patients in the device group will be asked to train specific movements repeatedly with the device for 45 minutes five days a week for 6 weeks and compliance will be monitored through training logs and remotely<br>|
| No Intervention: Conventional non-device home training program<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale | Measure of impairments in motor functioning and recovery in children post hemiplegia. | 6 Weeks | 
| Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test |  | 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Pediatrics, Arm, Upper limb, bimanual training, physical training