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NCT03135145 · ClinicalTrials.gov registry record · NA
Post-operative Lite Run Study
A NA study, sponsored by Gillette Children's Specialty Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03135145 is a NA study that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 10 participants.
The verdict
NCT03135145, a NA study, has completed, sponsored by Gillette Children's Specialty Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Lite Run Gait Trainer
- OTHER Usual Treatments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-05-15 |
| Est. Completion | 2019-09-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03135145
The ClinicalTrials.gov registry entry for NCT03135145 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gillette Children's Specialty Healthcare, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lite Run Gait Trainer is the first listed.
NCT03135145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03135145 about?
NCT03135145 is a clinical study titled "Post-operative Lite Run Study". 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-operati...
What is the current status of trial NCT03135145?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-05-15. Estimated completion is 2019-09-15.
What interventions are being tested in trial NCT03135145?
The interventions under investigation include: Lite Run Gait Trainer (DEVICE), Usual Treatments (OTHER).
Who is sponsoring clinical trial NCT03135145?
This trial is sponsored by Gillette Children's Specialty Healthcare, which has 12 total clinical trials registered on ClinicalTrials.gov.
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