- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387449
Adaptive Arm Training for Children With Hemiplegia
January 5, 2022 updated by: Blythedale Children's Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Hartsdale, New York, United States, 10530
- Kathleen M Friel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bimanual Arm Training
Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Assisting Hand Assessment
Time Frame: Before intervention compared to after intervention
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The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.
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Before intervention compared to after intervention
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Change in Box and Box Test
Time Frame: Before intervention compared to after intervention
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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.
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Before intervention compared to after intervention
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Change in range of motion
Time Frame: Before intervention compared to after intervention
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The robotic device measures range of motion of the shoulder.
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Before intervention compared to after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2017
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
December 22, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
January 2, 2018
Study Record Updates
Last Update Posted (Actual)
January 10, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAT_Friel
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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