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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819011
• Other study ID #: H-38050
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: April 4, 2019

Study information

• Verified date: February 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 4, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Bijan Najafi, PhD	Orthotic Holdings, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):299-30 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Fall Incidents	Fall incidents during the study	Baseline, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stride Velocity	stride velocity measured in single-task walking with normal speed	baseline, 6 months
Secondary	Stride Time	stride time measured in single task walking with normal speed	baseline, 6 months
Secondary	Stride Length	stride length measured in single-task walking with normal speed	baseline, 6 months