Adaptive Arm Training for Children With Hemiplegia

Cerebral Palsy Clinical Trial

Official title:

Adaptive Arm Training for Children With Hemiplegia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03387449
• Other study ID #: BAT_Friel
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Blythedale Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy
• Hemiparesis
• Hemiplegia
• Paresis

Intervention

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.

Locations

Country	Name	City	State
United States	Kathleen M Friel	Hartsdale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Blythedale Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in range of motion	The robotic device measures range of motion of the shoulder.	Before intervention compared to after intervention