Back to resultsHome Based Adaptive Arm Training for Children
Primary Purpose
Hemiplegia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
m2 Bimanual Arm Trainer (BAT)
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia focused on measuring Children, Pediatrics, Arm, Upper limb, bimanual training, physical training
Eligibility Criteria
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
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bimanual-to-unimanual device home training program
Conventional non-device home training program
Arm 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.
Outcomes
Primary Outcome Measures
Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02751502
Brief Title
Home Based Adaptive Arm Training for Children
Official Title
Home Based Adaptive Arm Training for Children With Hemiplegia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
lack of enrollment and funding + Covid-19 pandemic
Study Start Date
January 2017 (undefined)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Children, Pediatrics, Arm, Upper limb, bimanual training, physical training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimanual-to-unimanual device home training program
Arm Type
Experimental
Arm Title
Conventional non-device home training program
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
m2 Bimanual Arm Trainer (BAT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
Description
Measure of impairments in motor functioning and recovery in children post hemiplegia.
Time Frame
6 Weeks
Title
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renat Sukhov, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Home Based Adaptive Arm Training for Children
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