OHI Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovation Custom AFO
Principal Investigator: Bijan Najafi, Ph.D.
Foot problems, loss of foot sensation, and decreases in ankle strength and range of motion associated with aging have been tied to deteriorations in balance and increases the risk for falls. Ankle foot orthoses (AFO) are intended to keep the foot and ankle in optimal positions and are commonly prescribed with the intent of improving gait and balance, which in turn may reduce risk of falling.
We propose a randomized control trial to evaluate long-term benefit and effectiveness of an innovative custom AFO (Orthopedic Holdings Inc) in improving balance and reducing risk of falling in older adults. Intervention group will receive the AFO. Control group will be provided standard shoes recommended for older adults. Both groups will be assessed at baseline, two weeks (for intervention group), one month, three months, and six months. Each participant will be compensated $20 per visit.
Inclusion Criteria: Male or female - 65 years or older and have high risk of fall (confirmed by either a fall in the past six months or in clinic assessment)
Exclusion Criteria: Non-ambulatory or unable to stand without help or walk a distance of at least six feet without assistance; Patients currently on immunosuppressive drugs; Patients with acute fractures of the foot, wound, or major foot amputation; Patients with acute heart failure; Participants in an interventional study within the last 30 days; Patients unable or unwilling to participate in all procedures and follow-up evaluations.
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