Evidence map›Paper›PMID 31931855›Full record

ArticleTrials2020

Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I.

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

2 registry-linked trialsOpen 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 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 20% 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.

NCT04011267 nacompletednot on this map

Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2019 to 2022Enrolled62ConditionsDiabetic NeuropathiesArmsPhysical therapy by foot-ankle segmental and functional exercises
NCT06292468 nacompletednot on this mapstarted 2023, after this paper: background citation

Effects of Plantar Cutaneous Sensory Stimulation on Foot Tactile Sensitivity, Postural Control, and Spatiotemporal Gait Parameters in Patients With Diabetic Neuropathy

TypeinterventionalSponsorRiphah International UniversityRan2023 to 2023Enrolled50ConditionsDiabetic NeuropathiesArmsTraditional physical therapy, Plantar cutaneous sensory stimulation
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
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 2 institutions in 1 country.

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 JuniorDepartment 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 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.
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.
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.
D S PereiraDepartment 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.
C D SartorDepartment of Physical Therapy, Ibirapuera University, São Paulo, SP, 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 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 part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. METHODS/

designFootcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance. DISCUSSION: As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness.

trial registrationClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

Indexed as

Exercise TherapySelf CareAdolescentAdultAgedBiomechanical PhenomenaBrazilDiabetic FootDiabetic NeuropathiesEquivalence Trials as TopicFemaleFootGaitHumansMaleMiddle AgedDiabetic footeHealthFoot-related exercisesMusculoskeletal functionPreventive careRehabilitation technologySelf-management

Identifiers

PMID31931855
PMCPMC6958734
OpenAlexW3004642033

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.