A Phase 1 interventional study of mobility training with dynamic body weight support in Developmental Delay and Cerebral Palsy, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 12 Months to 36 Months. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Treatment
Background:
- 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.
Objectives:
- 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.
Eligibility:
- 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.
Design:
The purpose of this pilot study is to test the feasibility and effects of a functional mobility training program on the motor ability and physical activity of young children who are developmentally delayed and at risk for cerebral palsy (CP). The study includes a sample of 10 participants between 12-36 months of age who have at least a 4 month motor delay and are at risk for CP in a single-subject research design with repeated measures during baseline and intervention phases. Participants will have biweekly assessments during the 6 week baseline phase and the subsequent 6 week mobility training phase, followed by a final assessment after 6 weeks of treatment withdraw. Assessments and training will occur in the Functional and Applied Biomechanics (FAB) section. The mobility training program consists of three days per week of 30 minute treatment sessions using dynamic body weight support during a variety of functional motor tasks. Children will be assisted, but not limited, by the dynamic weight support system while they are encouraged to participate in a variety of age-appropriate mobility tasks. It is hypothesized that this system combined with the functional activity practice will facilitate the development of postural control and strength, and thereby improve walking ability. The primary outcome measures are completion rate and gross motor ability as measured by the Gross Motor Function Measure (GMFM). Secondary outcome measures include the amount of gross motor delay as measured by the Bayley Motor Scale (BMS),, the Functional Mobility Scale (FMS), spatiotemporal gait measures, and amount of physical activity in daily life. Results of this pilot study will be used to refine the mobility training program, evaluate the appropriateness of the selected outcome measures, and to provide preliminary data for a larger scale clinical trial.
150 studies on the registry are indexed under Learning Disabilities; 51 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 101 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
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12-36 months of age
EXCLUSION CRITERIA:
Change in motor delay
Completion rate, change in gross motor function, change in functional mobility, change in walking speed, change in physical activity
The record gives a start of Nov 2010, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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