OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Arthritis, Cancer, Cancer, Parkinsons Disease, Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Neurology, Oncology, Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 1/30/2019 |
| Start Date: | May 2016 |
| End Date: | December 15, 2018 |
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
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
Inclusion Criteria:
- Age 65 or older
- High concerns or high risk of fall
- Ambulatory
Exclusion Criteria:
- Presence of an active wound infection on either of the foot and ankle
- Use of medication or a medical condition that may have unstable (fluctuate over time)
or temporary (less than one month) impact on gait and balance
- Acute fractures on the foot
- Participant of an interventional study within the last 30 days
- Non-ambulatory or unable to stand without help or walk a distance of at least 1.8 m
(~six feet) without assistance
- Major foot amputation
- Unable or unwilling to participate in all procedures
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