Clinical trial · Interventional
OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accidental Falls | — | UNRESOLVED | — |
| Arthritis | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Diabetes | — | UNRESOLVED | — |
| End Stage Renal Failure on Dialysis | — | UNRESOLVED | — |
| Fall Due to Loss of Equilibrium | — | UNRESOLVED | — |
| High Risk of Falls Due to Mobility Limitation | — | UNRESOLVED | — |
| Parkinson's Disease | — | UNRESOLVED | — |
| Peripheral Arterial Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| MBB AFO | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MBB AFO 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.
- interventionNames
- Device: MBB AFO
- type
- ACTIVE_COMPARATOR
- label
- No MBB AFO Group
- description
- This group will be provided with a pair of New Balance 813 shoes for the duration of the study.
- interventionNames
- Other: Control
Primary outcomes (3)
- measure
- Hip Sway Change From Baseline to 6 Months
- timeFrame
- baseline to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTWang 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
- RESULTWang 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