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NCT02819011 · ClinicalTrials.gov registry record · Phase 2
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
A Phase 2 study, sponsored by Bijan Najafi, PhD.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT02819011: Completed Phase 2 study, sponsored by Bijan Najafi, PhD.
NCT02819011 is a Phase 2 study that has completed, run by Bijan Najafi, PhD. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02819011, a Phase 2 study, has completed, sponsored by Bijan Najafi, PhD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults. Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty status, and adverse events Secondary Endpoints • Characterize the Impact of MBB AFO on spontaneous daily physical activities • Characterize the feasibility of the MBB AFO device on patient adherence, acceptability, user-friendliness, and perception of benefit for daily usage
Primary Outcome
Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Interventions
- OTHER Control
- DEVICE MBB AFO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-05 |
| Est. Completion | 2019-04-04 |
| Phase | Phase 2 |
What the finished NCT02819011 record still lists
NCT02819011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT02819011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02819011 about?
NCT02819011 is a clinical study titled "OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO". The investigators propose a randomized control trial to evaluate long term effects and effectiveness of Moore Balance Brace (MBB) ankle foot orthoses (AFO) in reducing risk of falling in older adults. Primary Endpoints • Characterize the impact of MBB AFO on balance, gait, risk of falling, frailty ...
What is the current status of trial NCT02819011?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2016-05. Estimated completion is 2019-04-04.
What interventions are being tested in trial NCT02819011?
The interventions under investigation include: Control (OTHER), MBB AFO (DEVICE).
Who is sponsoring clinical trial NCT02819011?
This trial is sponsored by Bijan Najafi, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02819011's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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