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Clinical Trials/NCT02751502
NCT02751502
Terminated
Not Applicable

Home Based Adaptive Arm Training for Children With Hemiplegia

NYU Langone Health1 site in 1 country4 target enrollmentJanuary 2017
ConditionsHemiplegia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
NYU Langone Health
Enrollment
4
Locations
1
Primary Endpoint
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
February 9, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test

Time Frame: 6 Weeks

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.

Study Sites (1)

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