Evidence map›Paper›PMID 34117342›Full record

Trial reportScientific reports2021

Feasibility of a home-based foot-ankle exercise programme for musculoskeletal dysfunctions in people with diabetes: randomised controlled FOotCAre (FOCA) Trial II.

Érica Q Silva, Danilo P Santos, Raquel I Beteli, Renan L Monteiro, Jane S S P Ferreira, Ronaldo H Cruvinel-Junior, Asha Donini, Jady L Verissímo, Eneida Y Suda, Isabel C N Sacco

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

Trial report in Scientific reports, 2021. 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 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. 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

10 authors at 1 institution in 1 country.

Érica Q SilvaDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Danilo P SantosDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Raquel I BeteliDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Renan L MonteiroDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Jane S S P FerreiraDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Ronaldo H Cruvinel-JuniorDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Asha DoniniDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Jady L VerissímoDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Eneida Y SudaDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil.
Isabel C N SaccoDepartment of Physical Therapy, Speech, and Occupational Therapy, Faculdade de Medicina, Universidade de São Paulo, Rua Cipotânea, 51, Cidade Universitária, São Paulo, SP, 05360-160, Brazil. icnsacco@usp.br.
Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study sought to assess the feasibility of design, adherence, satisfaction, safety and changes in outcomes followed by a home-based foot-ankle exercise guided by a booklet in individuals with diabetic peripheral neuropathy (DPN). 20 participants were allocated usual care [control group (CG)] or usual care plus home-based foot-ankle exercises [intervention group (IG)] for 8 weeks. For feasibility, we assessed contact, preliminary screening and recruitment rates, adherence, and using a 5-point Likert scale to satisfaction and safety of the booklet. In the IG, we assessed preliminary changes in DPN symptoms, DPN severity (classified by a fuzzy model) and foot-ankle range of motion between baseline and Week 8. In the first 20 weeks, 1310 individuals were screened for eligibility by phone contact. Contact rate was 89% (contacted participants/20w), preliminary screening success 28% (participants underwent screening/20w), and recruitment rate 1.0 participants/week (eligible participants/20w). The recruitment rate was less than the ideal rate of 5 participants/week. The adherence to the exercises programme was 77%, and the dropout was 11% and 9% for the IG and CG, respectively. In the IG, participants' median level of satisfaction was 4 (IQR: 4-5) and perceived safety was 3 (IQR: 3-5). IG significantly decreased the DPN severity (p = 0.020), increased hallux relative to forefoot (first metatarsal) range of motion (ROM) (p < 0.001) and decreased maximum forefoot relative to hindfoot (midfoot motion) dorsiflexion during gait (p = 0.029). The home-based programme was feasible, satisfactory, safe and showed preliminary positive changes in DPN severity and foot motion during gait.Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745 .

Indexed as

ExerciseHome Care ServicesPhysical Therapy ModalitiesAnkleBiomechanical PhenomenaDiabetic NeuropathiesFeasibility StudiesFootGaitHumansMusculoskeletal DiseasesPatient ComplianceSingle-Blind Method

Identifiers

PMID34117342
PMCPMC8196027
OpenAlexW3170440178

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.