Home Based Adaptive Arm Training for Children
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|ClinicalTrials.gov Identifier: NCT02751502|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : June 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemiplegia||Device: m2 Bimanual Arm Trainer (BAT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Home Based Adaptive Arm Training for Children With Hemiplegia|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
|Experimental: Bimanual-to-unimanual device home training program||
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
No Intervention: 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.
- 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.
- Change from baseline in timed performance of standardized manual activities measured by Hand Assessment Test [ Time Frame: 6 Weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751502
|Contact: Zena Moorefirstname.lastname@example.org|
|United States, New York|
|New York University Langone Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Zena Moore email@example.com|
|Principal Investigator: Renat Sukhov, MD|
|Principal Investigator:||Renat Sukhov||NYU Langone Health|