OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Accidental Falls
- Sponsor
- Bijan Najafi, PhD
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Ankle Sway Change From Baseline to 6 Months
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Bijan Najafi, PhD
Professor of Surgery
Baylor College of Medicine
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
Outcomes
Primary Outcomes
Ankle Sway Change From Baseline to 6 Months
Time Frame: baseline to 6 months
Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Hip Sway Change From Baseline to 6 Months
Time Frame: baseline to 6 months
Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Center of Mass (COM) Sway Change Baseline to 6 Months
Time Frame: baseline to 6 months
Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)
Secondary Outcomes
- Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))(6 months)
- Fall Incidents(Baseline, 12 months)
- Concern for Falling Change Form Baseline to 6 Months(Baseline, 6 months)
- Physical Activity Level(baseline to 6 months)
- Number of Participants With Adverse Events(assessed at 1, 3, 6, and 12 months, month 12 reported)
- Stride Velocity(baseline, 6 months)
- Stride Time(baseline, 6 months)
- Percentage of Participants Who Found the Device Useful and Easy to Use(6 months)
- Stride Length(baseline, 6 months)