Clinical trial NCT02819011: OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Official title: OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Keywords: Ankle Foot Orthoses
falls
Fall Prevention
Frailty
Concern for falls
Footwear
Mobility
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Orthotic Holdings, Inc.
First posted: 2016-06-30
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Hip Sway Change From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Ankle Sway Change From Baseline to 6 Months
timeFrame: baseline to 6 months
measure: Center of Mass (COM) Sway Change Baseline to 6 Months
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))
timeFrame: 6 months
measure: Fall Incidents
timeFrame: Baseline, 12 months
measure: Concern for Falling Change Form Baseline to 6 Months
timeFrame: Baseline, 6 months
measure: Physical Activity Level
timeFrame: baseline to 6 months
measure: Number of Participants With Adverse Events
timeFrame: assessed at 1, 3, 6, and 12 months, month 12 reported
measure: Percentage of Participants Who Found the Device Useful and Easy to Use
timeFrame: 6 months
measure: Stride Velocity
timeFrame: baseline, 6 months
measure: Stride Time
timeFrame: baseline, 6 months
measure: Stride Length
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Wang C, Goel R, Rahemi H, Zhang Q, Lepow B, Najafi B. Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial. Gerontology. 2019;65(3):299-307. doi: 10.1159/000494114. Epub 2018 Nov 30.
citation: Wang C, Goel R, Zhang Q, Lepow B, Najafi B. Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1656-1661. doi: 10.1111/jgs.15929. Epub 2019 Apr 24.