A Phase 2 interventional study of Power mobility in Cerebral Palsy, Arthrogryposis and Spinal Muscular Atrophy, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to participants aged 14 Months to 30 Months. Per ClinicalTrials.gov, last updated 2016-01-14.
Sponsored by University of Oklahoma · Phase 2, Interventional, and Treatment
The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 41 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Intervention included provision of power wheelchair and power mobility training program. Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.
Other: Power mobility
Children in the control group will not receive any additional intervention, but will continue to receive the early intervention or other services they were receiving prior to enrollment in this study.
Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.
Merrill-Palmer-Revised
Time frame: Entry, 6-months, and 12-months
Pediatric Evaluation of Disability Inventory
Time frame: Entry, 6-months, 12-months
Child Health Status
Time frame: Entry
Two-position object permanence test
Time frame: Entry, 6 months, 12 months
Nonspeech Test
Time frame: Entry, 6 month, 12 months
Home Observation Measure of the Environment
Time frame: Entry, 6 months, 12 months
Parenting Stress Inventory
Time frame: Entry, 6 months, 12 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Entry, 6 months, 12 months
Hollingshead Scale
Time frame: Entry
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University of Oklahoma