Adaptive Arm Training for Children With Hemiplegia

Not Applicable

• Conditions: Hemiplegia; Acquired Brain Injury; Cerebral Palsy; Hemiparesis
• Interventions: Device: Bimanual Arm Training

• Registration Number: NCT03387449
• Lead Sponsor: Blythedale Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-07
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bimanual Arm Training	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.

Primary Outcome Measures

Name	Time	Method
Change in Box and Box Test	Before intervention compared to after intervention	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.
Change in Assisting Hand Assessment	Before intervention compared to after intervention	The Assisting Hand Assessment evaluated how effectively children use their hands to complete bimanual tasks.
Change in range of motion	Before intervention compared to after intervention	The robotic device measures range of motion of the shoulder.

Trial Locations

Locations (1)

Kathleen M Friel; 🇺🇸 Hartsdale, New York, United States