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

Phase 2

Completed

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

Registration Number: NCT02819011

Lead Sponsor: Bijan Najafi, PhD

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hip Sway Change From Baseline to 6 Months	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)
Ankle Sway Change From Baseline to 6 Months	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)
Center of Mass (COM) Sway Change Baseline to 6 Months	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 Outcome Measures

Name	Time	Method
Stride Length	baseline, 6 months	stride length measured in single-task walking with normal speed
Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))	6 months	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?").
Fall Incidents	Baseline, 12 months	Fall incidents during the study
Concern for Falling Change Form Baseline to 6 Months	Baseline, 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.
Physical Activity Level	baseline to 6 months	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).
Number of Participants With Adverse Events	assessed at 1, 3, 6, and 12 months, month 12 reported	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.
Stride Velocity	baseline, 6 months	stride velocity measured in single-task walking with normal speed
Stride Time	baseline, 6 months	stride time measured in single task walking with normal speed
Percentage of Participants Who Found the Device Useful and Easy to Use	6 months	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.