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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751502
|Contact: Zena Mooreemail@example.com|
|United States, New York|
|New York University Langone Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Zena Moore firstname.lastname@example.org|
|Principal Investigator: Renat Sukhov, MD|
|Principal Investigator:||Renat Sukhov||NYU Langone Health|