Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Nervous System Diseases

Musculoskeletal Diseases

Heart and Blood Diseases

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Diabetes Mellitus

Kidney Failure, Chronic

Renal Insufficiency

Parkinson Disease

Arthritis

Frailty

Peripheral Arterial Disease

Peripheral Vascular Diseases

Mobility Limitation

Vascular Diseases

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Neurodegenerative Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Atherosclerosis

Arteriosclerosis

Arterial Occlusive Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

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.

This group will be provided with a pair of New Balance 813 shoes for the duration of the study.

Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO

MBB AFO

Subjects will be provided with a pair of New Balance 813 shoes

Control

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

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

Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts

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 (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 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)

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?").

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 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 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.

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.

stride velocity measured in single-task walking with normal speed

stride time measured in single task walking with normal speed

stride length measured in single-task walking with normal speed

Orthotic Holdings, Inc.

Bijan Najafi, PhD

Professor of Surgery

Incident of falls related to footwear/AFO, pain, and other relevant adverse events such as callus, foot ulcers, etc

This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO): Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group

This group will be provided with a pair of New Balance 813 shoes for the duration of the study.

Control: Subjects will be provided with a pair of New Balance 813 shoes

No Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) Group

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Prof.Bijan Najafi

Repeated measures to compare changes in two groups from baseline to 6 months

Baseline

@6Month

Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data

Hip Sway Change From Baseline to 6 Months

Repeated measures to compare the changes in both groups from baseline to 6 months

Ankle Sway Change From Baseline to 6 Months

Center of Mass (COM) Sway Change Baseline to 6 Months

Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))

Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.

@12Month

Some participants in AFO and No AFO groups withdrew from study in 6 and 12 months. Generalized Estimating Equation Analysis can handle such missing data

Fall Incidents

Repeated measures to compare the changes between groups from baseline to 6 months

This group will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) for the duration of the study.

Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) : Subjects will be provided with a pair of New Balance 813 shoes plus a custom made Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO)

Spots Global Cancer Trial Database for OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

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