Home Based Adaptive Arm Training for Children

NYU Langone Health

Status: Terminated

Conditions: Hemiplegia

Treatments: Device: m2 Bimanual Arm Trainer (BAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02751502

15-01326

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Bimanual-to-unimanual device home training program

Experimental group

Treatment:

Device: m2 Bimanual Arm Trainer (BAT)

Conventional non-device home training program

No Intervention group

Description:

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.