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 2, 2018
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy Hemiplegia Hemiparesis Acquired Brain Injury||Device: Bimanual Arm Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Change in range of motion [ Time Frame: Before intervention compared to after intervention ]The robotic device measures range of motion of the shoulder.
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
|Contact: Kathleen M Friel, PhDemail@example.com|
|United States, New York|
|Kathleen M Friel||Recruiting|
|Hartsdale, New York, United States, 10530|
|Contact: Kathleen M Friel, PhD 914-368-3116 firstname.lastname@example.org|
|Sub-Investigator: Kathleen M Friel, PhD|