Home Based Adaptive Arm Training for Children

Hemiplegia Clinical Trial

Official title:

Home Based Adaptive Arm Training for Children With Hemiplegia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02751502
• Other study ID #: 15-01326
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: February 9, 2021

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia

Intervention

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

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale	Measure of impairments in motor functioning and recovery in children post hemiplegia.	6 Weeks
Primary	Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test		6 Weeks