Phase 2
N=44
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
Accidental Falls · Fall Due to Loss of Equilibrium · High Risk of Falls Due to Mobility Limitation · Diabetes · Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02819011 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Hip Sway Change From Baseline to 6 Months — 3.65; 3.75; 2.15; 3.89 degree^2 — p=0.040
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MBB AFO (Device); Control (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Bijan Najafi, PhD
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hip Sway Change From Baseline to 6 Months |
3.65; 3.75; 2.15; 3.89 | 0.040 sig |
| PRIMARY Ankle Sway Change From Baseline to 6 Months |
3.50; 3.21; 1.03; 3.56 | 0.005 sig |
| PRIMARY Center of Mass (COM) Sway Change Baseline to 6 Months |
0.71; 0.85; 0.32; 0.76 | 0.019 sig |
| SECONDARY Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO)) |
5.4; 5.6 | — |
| SECONDARY Fall Incidents |
2.27; 1.82; 0.80; 0.94 | 0.572 |
| SECONDARY Concern for Falling Change Form Baseline to 6 Months |
32.8; 33.3; 27.0; 30.1 | 0.650 |
| SECONDARY Physical Activity Level |
4017; 3847; 4872; 4297 | 0.756 |
| SECONDARY Number of Participants With Adverse Events |
0; 0 | — |
| SECONDARY Percentage of Participants Who Found the Device Useful and Easy to Use |
79; 93 | — |
| SECONDARY Stride Velocity |
0.80; 0.81; 0.88; 0.88 | 0.769 |
| SECONDARY Stride Time |
1.27; 1.24; 1.25; 1.21 | 0.857 |
| SECONDARY Stride Length |
0.98; 0.96; 1.05; 1.01 | 0.829 |
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
Data sourced from ClinicalTrials.gov (NCT02819011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.