Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01253083|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : April 20, 2018
- People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy.
- To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy.
- Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage.
- This study involves two 6-week study phases: a baseline phase and a mobility training program.
- Participants will be screened with a physical examination and medical history.
- During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking.
- Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions.
- After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All sessions will be videotaped.
- To evaluate the effects of the therapy program, participants will have testing sessions every 2 weeks.
- Parents/guardians will also complete questionnaires to provide feedback on the effectiveness of the therapy program.
|Condition or disease||Intervention/treatment||Phase|
|Developmental Delay Cerebral Palsy||Behavioral: mobility training with dynamic body weight support||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy - A Pilot Study|
|Study Start Date :||November 15, 2010|
|Actual Primary Completion Date :||June 6, 2014|
|Actual Study Completion Date :||June 6, 2014|
- Change in motor delay
- Completion rate, change in gross motor function, change in functional mobility, change in walking speed, change in physical activity
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): NCT01253083
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Diane L Damiano, Ph.D.||National Institutes of Health Clinical Center (CC)|