CompletedPhase 2

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

United States44 participantsStarted 2016-05

Plain-language 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

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hip Sway Change From Baseline to 6 Months

Timeframe: baseline to 6 months

Ankle Sway Change From Baseline to 6 Months

Timeframe: baseline to 6 months

Center of Mass (COM) Sway Change Baseline to 6 Months

Timeframe: baseline to 6 months

Trial details

NCT IDNCT02819011

SponsorBijan Najafi, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

Results submitted2020-01-16

View on ClinicalTrials.gov More Accidental Falls trials

Plain-language summary

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.