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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