Adaptive Arm Training for Children With Hemiplegia

NCT03387449 | Unknown FDA Device

• 1 other identifier: BAT_Friel
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Hemiplegia; Hemiparesis; Acquired Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Bimanual Arm Training

EXPERIMENTAL

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

Interventions

Bimanual Arm Training DEVICE

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.

Bimanual Arm Training

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blythedale Children's Hospital: lead

Study Sites (1)

Kathleen M Friel

Hartsdale, New York, 10530, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia; Paresis; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: November 7, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: during the study

Locations

US (1)