OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

Study Overview
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Brief Summary
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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

Official Title
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OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

Conditions
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Arthritis, Accidental Falls, Fall Due to Loss of Equilibrium, High Risk of Falls Due to Mobility Limitation, Diabetes, Cancer, Peripheral Arterial Disease, Parkinson's Disease, End Stage Renal Failure on Dialysis

Intervention / Treatment
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* Device: MBB AFO
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBB AFO Group<br>This group will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO for the duration of the study. | Device: MBB AFO<br>* Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO<br>|
| Active Comparator: No MBB AFO Group<br>This group will be provided with a pair of New Balance 813 shoes for the duration of the study. | Other: Control<br>* Subjects will be provided with a pair of New Balance 813 shoes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Sway Change From 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) | baseline to 6 months | 
| Ankle Sway Change From 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) | baseline to 6 months | 
| Center of Mass (COM) Sway Change 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) | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO)) | The adherence of participants to the prescribed Ankle-Foot Orthosis (AFO) plus walking shoes was quantified using the response to a self-reported question (How many hours per day did you wear the prescribed footwear?). | 6 months | 
| Fall Incidents | Fall incidents during the study | Baseline, 12 months | 
| Concern for Falling Change Form Baseline to 6 Months | Concern for falling is quantified by Falls Efficacy Scale - International (FES-I) questionnaire. Scores range from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). Higher score indicate worse performance. | Baseline, 6 months | 
| Physical Activity Level | Physical activity level for 24 hours while wearing their own shoes compared to the walking shoes and compared to walking shoes plus Ankle-Foot Orthosis (AFO). To quantify physical activity, number of taken steps per day was monitored using a pendant wearable sensor called, PAMSys (Biosensics, MA, USA). | baseline to 6 months | 
| Number of Participants With Adverse Events | Number of participants with adverse events reported during the study. Adverse events was inquired at 1 months, 3 months, 6 months, 12 months after the baseline, and summed at 12 months. If the participant has at least one adverse event reported in any assessed time frame, the participant will be categorized as the participant with adverse event. | assessed at 1, 3, 6, and 12 months, month 12 reported | 
| Percentage of Participants Who Found the Device Useful and Easy to Use | The participants perceived usefulness of ease of use of wearing Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) based on questionnaires of A technology acceptance model (TAM). Perceived usefulness was assessed using two questions (i.e., I feel more stable when standing, and I feel more stable when walking). Perceived ease of use was assessed using two questions (i.e., Was easy to take on and off, and Was comfortable to wear). The Likert scale (6-point scale from 0-5) was used to quantify how much they disagreed with each statement, including strongly disagree, disagree, somewhat disagree, somewhat agree, agree, and strongly agree, respectively. In this paper, responses were only categorized as positive (3-5 points) or negative (0-2 points) attitudes towards the use of AFO plus walking shoes. | 6 months | 
| Stride Velocity | stride velocity measured in single-task walking with normal speed | baseline, 6 months | 
| Stride Time | stride time measured in single task walking with normal speed | baseline, 6 months | 
| Stride Length | stride length measured in single-task walking with normal speed | baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle Foot Orthoses, falls, Fall Prevention, Frailty, Concern for falls, Footwear, Mobility