Evidence map›Paper›PMID 30504728›Full record

Trial reportGerontology2019

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.

Changhong Wang, Rahul Goel, Hadi Rahemi, Qianzi Zhang, Brian Lepow, Bijan Najafi

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gerontology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02819011 (OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02819011 phase2completednot on this map

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

TypeinterventionalSponsorBijan Najafi, PhDRan2016 to 2019Enrolled44ConditionsAccidental Falls, Fall Due to Loss of Equilibrium, High Risk of Falls Due to Mobility Limitation, DiabetesArmsMBB AFO, Control
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  6. Modifiable determinants of older adults' physical activity and sedentary behavior in community and healthcare settings: a DE-PASS systematic review and meta-analysis.European review of aging and physical activity : official journal of the European Group for Research into Elderly and Physical Activity · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Changhong WangInterdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Rahul GoelInterdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Hadi RahemiInterdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Qianzi ZhangMichael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Brian LepowDivision of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Bijan NajafiInterdisciplinary Consortium on Advanced Motion Performance (iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, USA, najafi.bijan@gmail.com.
Baylor College of Medicine · USMichael E. DeBakey VA Medical Center · US

Funding

Phase II STTR: Portable Device for Telecare Monitoring of Elderly PeopleR42AG032748 · NIA · BIOSENSICS, LLC · PI GWIN, JOSEPH T, MOHLER, MARTHA JANE · 2012 to 2016
$2.7M
NIA NIH HHS R42 AG032748
6 · The paper itself

Abstract

backgroundFoot problems are prevalent in older adults, which may increase the risk and concern for falls. Ankle-foot orthoses (AFO) have been shown to be effective in the stabilization of lower extremities, but their long-term effectiveness in improving balance and their potential to encourage older adults to become more physically active are still debated.

objectiveThis randomized controlled trial investigated the effectiveness of daily use of a custom-made AFO on balance, fear of falling, and physical activity in older adults. STUDY

designForty-four older adults with concern about or at risk for falling were randomly allocated to either the control group (CG; 77.3% female, age 75.6 ± 6.5 years, BMI 29.3 ± 6.4) or the intervention group (IG; 63.6% female, age 73.7 ± 6.3 years, BMI = 27.8 ± 4.8). The IG received walking shoes and bilateral custom-made AFO. The CG received only walking shoes. At the baseline and 6-month follow-ups, balance and physical activity were assessed using validated wearable instrumentation and fear of falling was assessed using the Fall Efficacy Scale-International (FES-I). Adherence and acceptability toward wearing the AFO were assessed using self-reported questionnaires at the 6-month follow-up.

resultsNo significant between-group difference was observed at baseline (p = 0.144-0.882). Compared to baseline and the CG, hip, ankle, and center-of-mass (COM) sways were significantly reduced at the 6-month follow-up in the IG while standing with the feet together during the eyes-open condition (p = 0.005-0.040). Within the IG, the FES-I was reduced significantly (p = 0.036) and there was an increasing trend in the number of walking bouts with a medium effect size (d = 0.52, p = 0.440) compared to baseline. However, there were no significant changes in FES-I and physical activity measures in the CG (p = 0.122-0.894). The reduction in COM sway in the IG was moderately correlated with adherence (r = -0.484, p = 0.047) and strongly correlated with baseline COM sway (r = -0.903, p < 0.001).

conclusionResults suggest that bilateral custom-made AFO plus walking shoes is effective in improving balance compared to walking shoes alone, and it significantly reduces the fear of falling, with a nonsignificant but noticeable positive trend in physical activity, compared to baseline. The results also suggest that older adults with poor balance at baseline and higher daily adherence to using the AFO will gain more benefit from the AFO intervention.

Indexed as

Foot OrthosesAccidental FallsAgedAged, 80 and overAnkle JointExerciseFearFemaleFootGeriatricsHumansMalePatient CompliancePatient SatisfactionPostural BalanceShoesAnkle-foot orthosesBalanceFear of fallingOlder adultsPhysical activity

Identifiers

PMID30504728
PMCPMC6530116
OpenAlexW2902986627

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.