Evidence map›Paper›PMID 31574862›Full record

ArticleMedicine2019

Effect of ankle-foot orthosis on functional mobility and dynamic balance of patients after stroke: Study protocol for a randomized controlled clinical trial.

Gabriela Vieira de Paula, Taís Regina da Silva, Juli Thomaz de Souza, Gustavo José Luvizutto, Silméia Garcia Zanati Bazan, Gabriel Pinheiro Modolo, Fernanda Cristina Winckler, Letícia Cláudia de Oliveira Antunes, Luís Cuadrado Martin, Rafael Dalle Molle da Costa and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

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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

11 authors at 2 institutions in 2 countries.

Gabriela Vieira de PaulaRehabilitation Department.
Taís Regina da SilvaRehabilitation Department.
Juli Thomaz de SouzaDepartment of Internal Medicine.
Gustavo José LuvizuttoDepartment of Applied Physical Therapy. Federal University of Triângulo Mineiro (UFTM), Uberaba, MG-BRA.
Silméia Garcia Zanati BazanDepartment of Internal Medicine.
Gabriel Pinheiro ModoloDepartment of Neurology, Psychology and Psychiatry. Sao Paulo State University (UNESP). Botucatu Medical School, Botucatu, SP-BRA, Brazil.
Fernanda Cristina WincklerDepartment of Internal Medicine.
Letícia Cláudia de Oliveira AntunesRehabilitation Department.
Luís Cuadrado MartinDepartment of Internal Medicine.
Rafael Dalle Molle da CostaRehabilitation Department.
Rodrigo BazanDepartment of Neurology, Psychology and Psychiatry. Sao Paulo State University (UNESP). Botucatu Medical School, Botucatu, SP-BRA, Brazil.
National Rehabilitation Center · KRUniversidade Federal do Triângulo Mineiro · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionStroke is the principal cause of impairment in the motor function and gait of adults. One of the resources used in rehabilitation to optimize gait is a prescription of ankle-foot orthosis (AFO), and the most prescribed AFOs are Fixed AFO and Articulated AFO; however, it is not known which of these options is more effective for these individuals. The aim of this study is to evaluate the impact of different types of ankle-foot orthosis functional mobility and dynamic balance in stroke patients.

methodsProspective randomized controlled clinical trial with 2 parallel groups will be conducted, and the aim is to recruit 50 patients with stroke diagnosis within 1 year, who indicated that they use both types of orthotics, who had a previous Rankin score less than or equal to 3, and who obtained AFO orthosis through the Hospital Clinics at the Botucatu Medical School (HCBMS) São Paulo, Brazil. After a specific evaluation by a physiotherapist, the patient will receive 1 of the AFO types via randomization. After 30 days, the patient will be reevaluated. The primary outcomes will be balance and mobility, which will be evaluated by the Time Up Go Test (TUG) and Tinetti's Scale of Mobility and Balance (TSMB). The secondary outcomes will be quality of life and the levels of anxiety and depression, which will be evaluated with the European (5D) Quality of Life Scale (Euroqol) and Hospital Anxiety and Depression Scale (HADS). Group allocation will be not concealed because the blinding of participants and of therapists that provide intervention is not possible, and all analyses will be based on an intention-to-treat principle. This study was approved by the Human Research Ethics Committee of the São Paulo State University UNESP, number 2.367.953. The results will be published in relevant journal. DISCUSSION: The results of this study will contribute to clinical practice by identifying the type of AFO orthosis that is more suitable for this condition, helping to standardize prescription of these orthoses by professionals, and guiding future research studies on this subject, which is still incompletely defined in the literature.

trial registrationRBR-6SF2VV (March 5, 2018).

Indexed as

Gait Disorders, NeurologicQuality of LifeStroke RehabilitationAdultAnkleAnkle JointBiomechanical PhenomenaEquipment DesignFemaleFoot OrthosesHumansMalePostural BalanceRandomized Controlled Trials as TopicRange of Motion, ArticularRecovery of Function

Identifiers

PMID31574862
PMCPMC6775434
OpenAlexW2975627733

What OpenQuestion holds

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Registered trials

None linked

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.