Home Based Adaptive Arm Training for Children

NCT02751502 | Terminated Results FDA Device

• 1 other identifier: 15-01326
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Children; Pediatrics; Arm; Upper limb; bimanual training; physical training

Outcome Measures

Primary Outcomes (2)

• 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

• Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test

  6 Weeks

Study Arms (2)

Bimanual-to-unimanual device home training program

EXPERIMENTAL

Device: m2 Bimanual Arm Trainer (BAT)

Conventional non-device home training program

NO INTERVENTION

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.

Interventions

m2 Bimanual Arm Trainer (BAT) 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

Bimanual-to-unimanual device home training program

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Acquired Brain Injury at least 3 months prior to enrollment.
• Unilateral hemiparesis
• History of compliance with home exercise programs in the past.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Renat Sukhov, MD
• Organization: NYU Langone Health

Renat.Sukhov@nyulangone.org

347-377-5138

Study Officials

• Renat Sukhov, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 26, 2016
• Study Start: January 1, 2017
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: February 11, 2022
• Results First Posted: February 11, 2022

Record last verified: 2022-02

Locations

US (1)