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Home Based Adaptive Arm Training for Children

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ClinicalTrials.gov Identifier: NCT02751502
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.


Condition or disease Intervention/treatment Phase
Hemiplegia Device: m2 Bimanual Arm Trainer (BAT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home Based Adaptive Arm Training for Children With Hemiplegia
Study Start Date : January 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bimanual-to-unimanual device home training program Device: m2 Bimanual Arm Trainer (BAT)
Patients in the device group will be asked to train specific movements repeatedly with the device for 45 minutes five days a week for 6 weeks and compliance will be monitored through training logs and remotely

No Intervention: Conventional non-device home training program
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.



Primary Outcome Measures :
  1. 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.

  2. Change from baseline in timed performance of standardized manual activities measured by Hand Assessment Test [ Time Frame: 6 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751502


Contacts
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Contact: Zena Moore zena.moore@nyumc.org

Locations
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United States, New York
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Zena Moore       zena.moore@nyumc.org   
Principal Investigator: Renat Sukhov, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Renat Sukhov NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02751502     History of Changes
Other Study ID Numbers: 15-01326
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

Keywords provided by NYU Langone Health:
Children
Pediatrics
Arm
Upper limb
bimanual training
physical training

Additional relevant MeSH terms:
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Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms