Trials / Completed
CompletedNCT02819011
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Bijan Najafi, PhD · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Accidental Falls
- Fall Due to Loss of Equilibrium
- High Risk of Falls Due to Mobility Limitation
- Diabetes
- Arthritis
- Cancer
- Peripheral Arterial Disease
- Parkinson's Disease
- End Stage Renal Failure on Dialysis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MBB AFO | Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO |
| OTHER | Control | Subjects will be provided with a pair of New Balance 813 shoes |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-12-01
- Completion
- 2019-04-04
- First posted
- 2016-06-30
- Last updated
- 2020-02-27
- Results posted
- 2020-02-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02819011. Inclusion in this directory is not an endorsement.