Home Based Adaptive Arm Training for Children

Not Applicable

Terminated

• Conditions: Hemiplegia
• Interventions: Device: m2 Bimanual Arm Trainer (BAT)

• Registration Number: NCT02751502
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-26
• Study Start: 2017-01
• Primary Completion: 2021-02-09
• Study Completion: 2021-02-09
• Results First Submitted: 2022-01-20
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Results First Posted: 2022-02-11
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Acquired Brain Injury at least 3 months prior to enrollment.
• Unilateral hemiparesis
• History of compliance with home exercise programs in the past.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimanual-to-unimanual device home training program	m2 Bimanual Arm Trainer (BAT)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States