Evidence map›Paper›PMID 31018018›Full record

Trial reportJournal of the American Geriatrics Society2019

Daily Use of Bilateral Custom-Made Ankle-Foot Orthoses for Fall Prevention in Older Adults: A Randomized Controlled Trial.

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

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

Trial report in Journal of the American Geriatrics Society, 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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
4.0field-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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
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

5 authors at 2 institutions in 1 country.

Changhong WangInterdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
Rahul GoelInterdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
Qianzi ZhangMichael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
Brian LepowMichael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
Bijan NajafiInterdisciplinary Consortium on Advanced Motion Performance, Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
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

objectiveTo examine the effects of bilateral custom-made ankle-foot orthoses (AFOs) to prevent falls for older adults with concern about or at risk for falling over 12-month daily use.

designSecondary analysis of a randomized controlled trial.

settingCommunity-dwelling older adults.

interventionHalf of the participants were randomly allocated to an intervention group (IG) that received fitted walking shoes and bilateral custom-made AFOs, and the other half were randomly allocated to a control group (CG) that only received fitted walking shoes. MEASUREMENTS: Self-reported fall history of 12-month duration was investigated at baseline and 12-month follow-up for both groups. Fall incidence rate and proportion of fallers were used as outcome measures to determine effects of 12-month footwear intervention in either group.

participantsAdults aged 65 years and older with concern about or at risk for falling (n = 44).

resultsNo significant between-group differences in participant characteristics were observed at the baseline (P = .144-.882). Within the IG, significant reductions were found in the fall incidence rate (P = .039) and the proportion of fallers (P = .036) at the 12-month follow-up compared to the baseline. Within the CG, no significant change was found at the 12-month follow-up compared to the baseline for the fall incidence rate (P = .217) or the proportion of fallers (P = .757). When comparing the IG with the CG, there was no significant difference in the change from the baseline to the 12-month follow-up for the fall incidence rate (P = .572) or the proportion of fallers (P = .080).

conclusionThis study failed to demonstrate a significant benefit of bilateral custom-made AFOs to reduce falls compared to fitted walking shoes. However, the AFO users had significant reductions in falls compared to the preceding year. A future study with a larger sample size is recommended to confirm these observations. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02819011. J Am Geriatr Soc 67:1656-1661, 2019.

Indexed as

Foot OrthosesShoesAccidental FallsAgedAged, 80 and overAnkleEquipment DesignFemaleHumansIndependent LivingMaleankle-foot orthosesfall preventionfootwearolder adults

Identifiers

PMID31018018
PMCPMC6684469
OpenAlexW2941052049

What OpenQuestion holds

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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.