OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

Completed · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT02819011

Run by

Bijan Najafi, PhD

People needed

44

Starts

2016-05-01

Expected to finish

2019-04-04

Last updated by the study team

2020-02-27

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 65 or older
• High concerns or high risk of fall
• Ambulatory

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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