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

ClinicalTrials.gov identifier: NCT02819011

Purpose: The investigators propose a randomized control trial to evaluate long-term effects and effectiveness of ankle foot orthoses (AFO) in reducing risk of falling in older adults.

Study type: Interventional

Study design: Randomized, safety/efficacy, parallel assignment, open label, supportive care

Estimated enrollment: 40

Eligibility criteria: Both genders eligible; ages 65 years and older. Patients must be at high risk of falling and ambulatory. Excludes patients with active wound infection, on immune suppressors, with acute fractures on the foot, with acute heart failure and with major foot amputation.

Study start date: May 2016

Estimated primary completion date: The final collection date for primary outcome measures will be May 2018.

Primary outcome measures: Gait-speed change and balance change from baseline to 1 month, 3 months and 6 months

Secondary outcome measures: Adherence through an acceptability questionnaire at 1 month, 3 months and 6 months

Sponsors and collaborators: Bijan Najafi and Orthotic Holdings Inc.

Contact: Bijan Najafi, PhD, 713-798-7536, bijan.najafi@bcm.edu; Ana L Enriquez, BS, 713-798-7537, ana.enriquez@bcm.edu

Information acquired from: Bijan Najafi, Baylor College of Medicine, via clinicaltrials.gov

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