Home Based Adaptive Arm Training for Children

NYU Langone Health logo

NYU Langone Health

Status

Terminated

Conditions

Hemiplegia

Treatments

Device: m2 Bimanual Arm Trainer (BAT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02751502
15-01326

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4 participants in 2 patient groups

Bimanual-to-unimanual device home training program
Experimental group
Treatment:
Device: m2 Bimanual Arm Trainer (BAT)
Conventional non-device home training program
No Intervention group
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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