Evidence map›Paper›PMID 33766146›Full record

ArticlePilot and feasibility studies2021

Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I.

Ronaldo H Cruvinel Júnior, Jane S S P Ferreira, Raquel I Beteli, Érica Q Silva, Jady L Veríssimo, Renan L Monteiro, Eneida Y Suda, Isabel C N Sacco

Registry-linked trialAbstract read
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In one paragraph

Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04011267 (Effect of Customized Software for Foot-related Exercises), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. 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

8 authors.

Ronaldo 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.
Jane 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.
Raquel I BeteliDepartment 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.
Érica 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.
Jady 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.
Renan 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.
Eneida 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.
Isabel 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.ORCID http://orcid.org/0000-0003-1254-0007

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 119178/2019Conselho Nacional de Desenvolvimento Científico e Tecnológico 28/2018 FOCA Trial 407252/2018-5Conselho Nacional de Desenvolvimento Científico e Tecnológico 304124/2018-4Coordenação 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 2019/06405-9
6 · The paper itself

Abstract

backgroundDiabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD).

methodsFourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group.

resultsIn 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants' median level of satisfaction was 5.0 (IQR: 4.5-5.0) and perceived safety was 5.0 (IQR: 5.0-5.0).

conclusionThe internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial.

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

Indexed as

Diabetic neuropathyeHealthFeasibility studyFoot-related exercisesMusculoskeletal functionPreventive careRehabilitation technologySelf-management

Identifiers

PMID33766146
PMCPMC7995736

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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.