Adaptive Arm Training for Children With Hemiplegia

The goal of this research is to provide limb training in children with hemiplegia using a bimanual-to-unimanual training approach. Twenty pediatric patients aged 5-17 years with acquired brain injury will receive training on the bimanual-to-unimanual device for a period of 9 weeks. During the training, children use both arms to operate robotic arms to play a video game. We will assess changes in hand impairment after the training.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy; Hemiplegia; Acquired Brain Injury; Hemiparesis
• Intervention / Treatment: Device: Bimanual Arm Training

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Hartsdale, New York, United States, 10530
      • Kathleen M Friel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hemiplegia due to brain injury at least 3 months before study enrollment.

Exclusion Criteria:

• Any social or medical problem that precludes compliance with the protocol.
• Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment.
• Implanted neuromodulatory or electronic device or other complicating illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bimanual Arm Training; Children in the study will all receive the same treatment, which includes 9 weeks of training on the bimanual arm trainer robotic device.

Device: Bimanual Arm Training; Device-based bimanual-to-unimanual training will be provided with the Bimanual Arm Trainer (BAT, Mirrored Motion Works, NC). The device provides bimanual-to-unimanual training of simultaneous shoulder external rotation and elbow extension, and independent training of pronation-supination and grasp and release of each hand. Range of motion and speed are recorded during training and feedback and motivation are provided through age-appropriate gaming modules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Assisting Hand Assessment	The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.	Before intervention compared to after intervention
Change in Box and Box Test	The Box and Blocks test measures how many blocks a child can move with one hand from one box to another in one minute with the impaired hand.	Before intervention compared to after intervention
Change in range of motion	The robotic device measures range of motion of the shoulder.	Before intervention compared to after intervention

Collaborators and Investigators

• Sponsor: Blythedale Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 22, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Paralysis; Cerebral Palsy; Brain Injuries; Hemiplegia; Paresis
• Other Study ID Numbers: BAT_Friel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We plan to share results with our collaborator Dr. Preeti Raghaven, at New York University. Dr. Raghavan created the robot we are using, has IRB approval to use the robot, and is a consultant on this study. Personal health information will not be shared.
• IPD Sharing Time Frame: during the study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes