Home Based Adaptive Arm Training for Children

February 10, 2022 updated by: NYU Langone Health

Home Based Adaptive Arm Training for Children With Hemiplegia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center

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:

  • 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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Weeks
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
Time Frame: 6 Weeks
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Renat Sukhov, MD, NYU Langone Health

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

January 1, 2017

Primary Completion (ACTUAL)

February 9, 2021

Study Completion (ACTUAL)

February 9, 2021

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (ESTIMATE)

April 26, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-01326

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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