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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: Completed NA study, sponsored by Gillette Children's Specialty Healthcare.
NCT03135145 is a NA study that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse events will be tracked for each subject enrolled in the study.
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 |
What the finished NCT03135145 record still lists
NCT03135145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Lite Run Gait Trainer is the first listed.
NCT03135145 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03135145's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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