Evidence map›Paper›PMID 32054510›Full record

ArticleTrials2020

Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial.

E Q Silva, E Y Suda, D P Santos, J L Veríssimo, J S S P Ferreira, R H Cruvinel Júnior, R L Monteiro, C D Sartor, I C N Sacco

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04008745 (Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% 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.

NCT04008745 nacompletednot on this map

Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2019 to 2021Enrolled50ConditionsDiabetic NeuropathiesArmsEducational and home-based physical therapy by foot-related exercises
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
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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

9 authors at 3 institutions in 1 country.

E Q SilvaDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
E Y SudaDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
D P SantosDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
J L VeríssimoDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
J S S P FerreiraDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
R H Cruvinel JúniorDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
R L MonteiroDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil.
C D SartorDepartment of Physical Therapy, Ibirapuera University, São Paulo, São Paulo, Brazil.
I C N SaccoDepartment of Physical Therapy, Speech, and Occupational Therapy, School of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária, São Paulo, São Paulo, 05360-160, Brazil. icnsacco@usp.br.
Universidade de São Paulo · BRUniversidade Federal do Amapá · BRUniversidade Ibirapuera · BR

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 304124/2018-4Conselho Nacional de Desenvolvimento Científico e Tecnológico 407252/2018-5Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Financial Code 001Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/15449-4Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/17848-3Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/02522-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/02624-8Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/06405-9
6 · The paper itself

Abstract

backgroundThis study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN. METHODS/

designThe FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot-ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality. DISCUSSION: The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot-ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks.

trial registrationClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.

Indexed as

Activities of Daily LivingAdolescentAdultAgedDiabetes Mellitus, Type 2Diabetic NeuropathiesExerciseFemaleFollow-Up StudiesFootHumansMaleMiddle AgedMuscle, SkeletalMuscle StrengthPamphletsClinical trialDiabetic footDiabetic neuropathiesExerciseFoot ulcerPhysical therapyPreventive care

Identifiers

PMID32054510
PMCPMC7020575
OpenAlexW3005727152

What OpenQuestion holds

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LicenceCC BY
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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.