Evidence map›Paper›PMID 40305524›Full record

ArticlePloS one2025

Impact of surgery on rehabilitation care and quality of life perceived by patient with post-stroke upper limb spasticity: Study protocol for a randomized controlled trial.

Patricia Hurtado-Olmo, Ángela González-Santos, Laura Del Olmo Iruela, Belén Castro-Ropero, Lourdes Zúñiga-Gómez, Ana Isabel Bueno-García, Pilar Guijosa-Campos, Basilio Gómez-Pozo, Fidel Hita-Contreras, Pedro Hernández-Cortés

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06392633 (SURGERY VS BOTULINUM TOXIN ON QUALITY OF LIFE IN STROKE PATIENTS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT06392633 naunknown statusnot on this map

Surgery vs botulinum toxin on quality of life in stroke patients

TypeinterventionalSponsorFundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalRan2021 to 2024Enrolled44ConditionsStrokeArmsspastic hand sugery, Botulinum Toxin A
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

10 authors.

Patricia Hurtado-OlmoUpper Limb Surgery Unit, Orthopedic Surgery Department, San Cecilio University Hospital of Granada, Spain.ORCID 0009-0001-0554-5590
Ángela González-SantosDepartment of Physical Therapy, Faculty of Health Science, University of Granada, Granada, Spain.ORCID 0000-0001-9023-043X
Laura Del Olmo IruelaRehabilitation Department, San Cecilio University Hospital of Granada, Granada, Spain.
Belén Castro-RoperoRehabilitation Department, San Cecilio University Hospital of Granada, Granada, Spain.
Lourdes Zúñiga-GómezRehabilitation Department, San Cecilio University Hospital of Granada, Granada, Spain.
Ana Isabel Bueno-GarcíaRehabilitation Department, San Cecilio University Hospital of Granada, Granada, Spain.
Pilar Guijosa-CamposUnidad Clínica de Prevención, promoción y vigilancia de la salud. Distrito Sanitario Granada SAS, Granada, Spain.
Basilio Gómez-PozoUnidad Clínica de Prevención, promoción y vigilancia de la salud. Distrito Sanitario Granada SAS, Granada, Spain.
Fidel Hita-ContrerasDepartment of Health Sciences, Faculty of Health Sciences, University of Jaén, Jaén, Spain.
Pedro Hernández-CortésUpper Limb Surgery Unit, Orthopedic Surgery Department, San Cecilio University Hospital of Granada, Spain.ORCID 0000-0001-9629-3140

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStroke is the principal cause of permanent disability in adult age, and many patients require lifelong medical treatment and care from others for their daily activities. It has enormous repercussions on the work and social lives of patients and their families and involves major economic expenditure. Post-stroke spastic upper limb is usually treated with rehabilitation, occupational therapy, and periodical injections of botulinum toxin, while surgical correction is now seldom considered. However, there has been no clinical trial to compare between surgical and toxin treatments. The primary aim of this study is to compare outcomes between surgery and a conventional approach with botulinum toxin in patients with post-stroke upper limb spasticity.

methodsA two-arm (surgical treatment [n = 22] vs. botulinum toxin [n = 22]) randomized clinical trial (RCT) will be performed to compare the efficacy of surgery with that of botulinum toxin treatment in patients with post-stroke upper limb spasticity. Data will be collected at baseline and at 6 and 12 months of follow-up on functionality, hygienic status, quality of life, sleep quality, anxiety/depression levels, and functional magnetic resonance imaging (fMRI)-measured brain activity. Healthcare and care costs will be compared between the groups. DISCUSSION: This research is set in the context of chronic diseases, aging, and functional/mobility limitations. The results can be expected to have a major impact, because the high prevalence of stroke and the severe associated disability means that an enormous number of patients can benefit from improved treatment protocols, and a more rational use of resources would yield considerable economic benefits for health and care systems. Our expectation is that outcomes would be more favorable with surgery. However, the aim is not to exclude any approach but rather to explore how the potential and indications of each treatment could be integrated within a multidisciplinary therapeutic protocol in a complementary manner. Trial Registration: ClinicalTrials.gov (NCT06392633). Registered on 30 April 2024.

Indexed as

Muscle SpasticityQuality of LifeStrokeStroke RehabilitationUpper ExtremityAdultBotulinum ToxinsFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeBotulinum Toxins

Identifiers

PMID40305524
PMCPMC12043160

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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.