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Clinical Trials/NCT03387449
NCT03387449
Unknown
Not Applicable

Adaptive Arm Training for Children With Hemiplegia

Blythedale Children's Hospital1 site in 1 country20 target enrollmentNovember 7, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Blythedale Children's Hospital
Enrollment
20
Locations
1
Primary Endpoint
Change in Box and Box Test
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2017
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in Box and Box Test

Time Frame: Before intervention compared to after intervention

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 Assisting Hand Assessment

Time Frame: Before intervention compared to after intervention

The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.

Change in range of motion

Time Frame: Before intervention compared to after intervention

The robotic device measures range of motion of the shoulder.

Study Sites (1)

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