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

Bijan Najafi, PhD

Status and phase: Completed; Phase 2

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

Treatments: Other: Control; Device: MBB AFO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02819011

H-38050

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

MBB AFO Group

Experimental group

Description:

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.

Treatment:

Device: MBB AFO

No MBB AFO Group

Active Comparator group

Description:

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

Treatment:

Other: Control