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Adaptive Arm Training for Children With Hemiplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03387449
Recruitment Status : Recruiting
First Posted : January 1, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

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
Cerebral Palsy Hemiplegia Hemiparesis Acquired Brain Injury Device: Bimanual Arm Training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : November 7, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Before intervention compared to after intervention ]
    The robotic device measures range of motion of the shoulder.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387449


Contacts
Contact: Kathleen M Friel, PhD 914-368-3116 kaf3001@med.cornell.edu

Locations
United States, New York
Kathleen M Friel Recruiting
Hartsdale, New York, United States, 10530
Contact: Kathleen M Friel, PhD    914-368-3116    kaf3001@med.cornell.edu   
Sub-Investigator: Kathleen M Friel, PhD         
Sponsors and Collaborators
Blythedale Children's Hospital
More Information

Responsible Party: Blythedale Children's Hospital
ClinicalTrials.gov Identifier: NCT03387449     History of Changes
Other Study ID Numbers: BAT_Friel
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: during the study
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Brain Injuries
Cerebral Palsy
Paresis
Hemiplegia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Neurologic Manifestations
Signs and Symptoms
Paralysis