NCT02751502

Home Based Adaptive Arm Training for Children

Home Based Adaptive Arm Training for Children With Hemiplegia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemiplegia

Interventions

Type	Name	Description
DEVICE	m2 Bimanual Arm Trainer (BAT)	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

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-02-09
• Completion: 2021-02-09
• First posted: 2016-04-26
• Last updated: 2022-02-11
• Results posted: 2022-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study