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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Cancer; Arthritis; Parkinson's Disease; Peripheral Arterial Disease; End Stage Renal Failure on Dialysis; Accidental Falls; Fall Due to Loss of Equilibrium; High Risk of Falls Due to Mobility Limitation
• Intervention / Treatment: Device: MBB AFO; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bijan Najafi, PhD
• Collaborators: Orthotic Holdings, Inc.

Publications and helpful links

General Publications

• Wang C, Goel R, Rahemi H, Zhang Q, Lepow B, Najafi B. Effectiveness of Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses on Balance, Fear of Falling, and Physical Activity in Older Adults: A Randomized Controlled Trial. Gerontology. 2019;65(3):299-307. doi: 10.1159/000494114. Epub 2018 Nov 30.
• Wang C, Goel R, Zhang Q, Lepow B, Najafi B. Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1656-1661. doi: 10.1111/jgs.15929. Epub 2019 Apr 24.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: falls; Mobility; Frailty; Footwear; Fall Prevention; Ankle Foot Orthoses; Concern for falls
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Atherosclerosis; Renal Insufficiency, Chronic; Parkinson Disease; Peripheral Arterial Disease; Peripheral Vascular Diseases; Kidney Failure, Chronic; Mobility Limitation
• Other Study ID Numbers: H-38050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts