Adaptive Arm Training for Children With Hemiplegia
Primary Purpose
Cerebral Palsy, Hemiplegia, Hemiparesis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bimanual Arm Training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Hemiplegia due to brain injury at least 3 months before study enrollment.
Exclusion Criteria:
- Any social or medical problem that precludes compliance with the protocol.
- Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment.
- Implanted neuromodulatory or electronic device or other complicating illness.
Sites / Locations
- Kathleen M Friel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bimanual Arm Training
Arm Description
Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device.
Outcomes
Primary Outcome Measures
Change in Assisting Hand Assessment
The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.
Change in Box and Box Test
The Box and Blocks test measures how many blocks a child can move with one hand from one box to another in one minute with the impaired hand.
Change in range of motion
The robotic device measures range of motion of the shoulder.
Secondary Outcome Measures
Full Information
NCT ID
NCT03387449
First Posted
December 22, 2017
Last Updated
January 5, 2022
Sponsor
Blythedale Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03387449
Brief Title
Adaptive Arm Training for Children With Hemiplegia
Official Title
Adaptive Arm Training for Children With Hemiplegia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blythedale Children's Hospital
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
The goal of this research is to provide limb training in children with hemiplegia using a bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with acquired brain injury will receive training on the bimanual-to-unimanual device for a period of 9 weeks. During the training, children use both arms to operate robotic arms to play a video game. We will assess changes in hand impairment after the training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegia, Hemiparesis, Acquired Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bimanual Arm Training
Arm Type
Experimental
Arm Description
Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device.
Intervention Type
Device
Intervention Name(s)
Bimanual Arm Training
Intervention Description
Device-based bimanual-to-unimanual training will be provided with the Bimanual Arm Trainer (BAT, Mirrored Motion Works, NC). The device provides bimanual-to-unimanual training of simultaneous shoulder external rotation and elbow extension, and independent training of pronation-supination and grasp and release of each hand. Range of motion and speed are recorded during training and feedback and motivation are provided through age-appropriate gaming modules.
Primary Outcome Measure Information:
Title
Change in Assisting Hand Assessment
Description
The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.
Time Frame
Before intervention compared to after intervention
Title
Change in Box and Box Test
Description
The Box and Blocks test measures how many blocks a child can move with one hand from one box to another in one minute with the impaired hand.
Time Frame
Before intervention compared to after intervention
Title
Change in range of motion
Description
The robotic device measures range of motion of the shoulder.
Time Frame
Before intervention compared to after intervention
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:
Hemiplegia due to brain injury at least 3 months before study enrollment.
Exclusion Criteria:
Any social or medical problem that precludes compliance with the protocol.
Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment.
Implanted neuromodulatory or electronic device or other complicating illness.
Facility Information:
Facility Name
Kathleen M Friel
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share results with our collaborator Dr. Preeti Raghaven, at New York University. Dr. Raghavan created the robot we are using, has IRB approval to use the robot, and is a consultant on this study. Personal health information will not be shared.
IPD Sharing Time Frame
during the study
Learn more about this trial
Adaptive Arm Training for Children With Hemiplegia
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