At a glance
ClinicalIndex Comparison Record- ✓Age 65 years or older
- ✓High concerns or high risk of fall
- ✓Ambulatory
- ✕Active wound infection on foot or ankle
- ✕Medication or medical condition causing unstable or temporary (less than one month) changes to gait and balance
- ✕Acute fractures on the foot
- ✕Participant in another interventional study within last 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
In Brief
A Phase 2 clinical trial evaluating MBB AFO and Control for Accidental Falls and 8 related conditions. Completed, enrolled 44 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO
Subjects will be provided with a pair of New Balance 813 shoes