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Adaptive Arm Training for Children With Hemiplegia

Sponsor
Blythedale Children's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03387449
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
60.8
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bimanual Arm Training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adaptive Arm Training for Children With Hemiplegia
Actual Study Start Date :
Nov 7, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. Change in range of motion [Before intervention compared to after intervention]

    The robotic device measures range of motion of the shoulder.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kathleen M Friel Hartsdale New York United States 10530

Sponsors and Collaborators

  • Blythedale Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blythedale Children's Hospital
ClinicalTrials.gov Identifier:
NCT03387449
Other Study ID Numbers:
  • BAT_Friel
First Posted:
Jan 2, 2018
Last Update Posted:
Jan 10, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Brain Injuries
Cerebral Palsy
Hemiplegia
Paresis

Study Results

No Results Posted as of Jan 10, 2022