Post-operative Lite Run Study
Completed · Not applicable
Conditions studied: Cerebral Palsy, Neurologic Disorder, Chromosome Abnormality, Spina Bifida
In brief
Lite Run is a new assistive device that may have FDA listing as a Class I device by mid 2017 based on clinical testing of adults, independent agency testing and in-house evaluations. This will be a combined study with multiple purposes with respect to the evaluation of its use with the post-operative pediatric population. A first purpose is to verify safety and feasibility of the device on pediatric patients. A second purpose is to statistically test the effectiveness of Lite Run to decrease physical burden on the therapist during post-operative gait training for children and adolescents with cerebral palsy as compared to current methods of body weight-supported gait training. A third purpose is to measure and qualitatively evaluate the effectiveness of the device on patient outcomes and improving patient and therapist satisfaction.
Key facts
- Study ID
- NCT03135145
- Run by
- Gillette Children's Specialty Healthcare
- People needed
- 10
- Starts
- 2017-05-15
- Expected to finish
- 2019-09-15
- Last updated by the study team
- 2021-02-21
Who can join
Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of cerebral palsy, neurologic syndrome, chromosomal abnormalities, spina bifida, or other neurological disorders
- age 4-17
- recent single event multilevel lower extremity orthopedic surgery or selective dorsal rhizotomy
- referred for physical therapy for mobility/gait training to regain functional walking and ambulation
You may not qualify if…
- Gross Motor Function Classification System levels I (walk and run in the community with only limitations in balance, coordination and speed) and V (use wheelchair to maintain sitting and for whole body mobility) prior to surgical intervention
- Subjects who are too large or too small to fit within the current Lite Run pants/prototype. The minimum patient weight is 50 lbs. The maximum patient weight is 350 lbs.
- Subjects that do not have clearance for full weight-bearing at the first treatment session
Where it is running
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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