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

NCT02819011 | Completed Phase 2 Results

• 1 other identifier: H-38050
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Ankle Foot Orthoses; falls; Fall Prevention; Frailty; Concern for falls; Footwear; Mobility

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

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

  6 months

• Fall Incidents

  Baseline, 12 months

• Concern for Falling Change Form Baseline to 6 Months

  Baseline, 6 months

• Physical Activity Level

  baseline to 6 months

• Number of Participants With Adverse Events

  assessed at 1, 3, 6, and 12 months, month 12 reported

Study Arms (2)

MBB AFO Group

EXPERIMENTAL

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

No MBB AFO Group

ACTIVE COMPARATOR

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

Other: Control

Interventions

MBB AFO DEVICE

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

MBB AFO Group

Control OTHER

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

No MBB AFO Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 or older
• High concerns or high risk of fall
• Ambulatory

You may not qualify if:

• 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

Sponsors & Collaborators

• Bijan Najafi, PhD: lead
• Orthotic Holdings, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related 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):299-307. doi: 10.1159/000494114. Epub 2018 Nov 30.

  PMID: 30504728 RESULT

• 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.

  PMID: 31018018 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Arthritis; Neoplasms; Peripheral Arterial Disease; Parkinson Disease; Frailty

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Joint Diseases; Musculoskeletal Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof.Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

17137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: April 4, 2019
• Last Updated: February 27, 2020
• Results First Posted: February 27, 2020

Record last verified: 2020-02

Locations

US (1)