Home Based Adaptive Arm Training for Children

NCT ID: NCT02751502

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-02-09

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.

Conditions

Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bimanual-to-unimanual device home training program

Group Type: EXPERIMENTAL

m2 Bimanual Arm Trainer (BAT)

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renat Sukhov, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University Langone Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-01326

Identifier Type: -

Identifier Source: org_study_id