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

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?").

Time frame: 6 months

Fall Incidents

Fall incidents during the study

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Stride Velocity

stride velocity measured in single-task walking with normal speed

Time frame: baseline, 6 months

Stride Time

stride time measured in single task walking with normal speed

Time frame: baseline, 6 months

Stride Length

stride length measured in single-task walking with normal speed

Time frame: baseline, 6 months