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http://hdl.handle.net/1942/41854
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DC Field | Value | Language |
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dc.contributor.author | Oosterbos, Christophe | - |
dc.contributor.author | Rummens, Sofie | - |
dc.contributor.author | BOGAERTS, Kris | - |
dc.contributor.author | Van Hoylandt, Anais | - |
dc.contributor.author | Hoornaert, Sophie | - |
dc.contributor.author | WEYNS, Frank | - |
dc.contributor.author | Dubuisson, Annie | - |
dc.contributor.author | Ceuppens, Jeroen | - |
dc.contributor.author | Schuind, Sophie | - |
dc.contributor.author | Groen, Justus L. | - |
dc.contributor.author | Lemmens , Robin | - |
dc.contributor.author | Theys , Tom | - |
dc.date.accessioned | 2023-11-20T09:59:57Z | - |
dc.date.available | 2023-11-20T09:59:57Z | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-11-20T08:58:13Z | - |
dc.identifier.citation | Pilot and Feasibility Studies, 9 (1) (Art N° 181) | - |
dc.identifier.uri | http://hdl.handle.net/1942/41854 | - |
dc.description.abstract | BackgroundBased on the lack of literature to support any treatment strategy in patients with foot drop due to peroneal nerve entrapment, a prospective study randomizing patients between surgery and conservative treatment is warranted. Since studies comparing surgery to no surgery are often challenging, we first examined the feasibility of such a randomized controlled trial.Methods/designAn internal feasibility pilot study was conducted to assess several aspects of process, resource, management, and scientific feasibility. The main objective was the assessment of the recruitment rate. The criterion to embark on a full study was the recruitment of at least 14 patients in 6 participating centers within 6 months. Cross-over rate, blinding measures, training strategies, and trial assessments were evaluated. The trial was entirely funded by the KCE Trials public funding program of the Belgian Health Care Knowledge Centre (ID KCE19-1232).ResultsThe initial duration was prolonged due to the COVID-19 pandemic. Between April 2021 and October 2022, we included 19 patients of which 15 were randomized. Fourteen patients were treated as randomized. One drop-out occurred after randomization, prior to surgery. We did not document any cross-over or accidental unblinding. Training strategies were successful. Patients perceived the quality of life questionnaire as the least relevant assessment. Assessment of ankle dorsiflexion range of motion was prone to interobserver variability. All other trial assessments were adequate.DiscussionRecruitment of the anticipated 14 patients was feasible although slower than expected. The Short-Form Health Survey (SF-36) and assessment of ankle dorsiflexion range of motion will no longer be included in the full-scale FOOTDROP trial.ConclusionThe FOOTDROP study is feasible.Trial registrationClinicalTrials.gov, identifier NCT04695834. Registered 4 January 2021. | - |
dc.description.sponsorship | The FOOT DROP trial is funded by the Belgian Knowledge Health Care Centre (KCE) and has KCE Trials Number KCE19-1232. Independent experts from KCE Trials advisory boards peer-reviewed the protocol of this randomized controlled trial repeatedly. The authors acknowledge the KCE for peer review of the protocol and their guidance throughout the internal feasibility pilot study. | - |
dc.language.iso | en | - |
dc.publisher | BMC | - |
dc.rights | The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | - |
dc.subject.other | Randomized controlled trial | - |
dc.subject.other | Foot drop | - |
dc.subject.other | Peroneal nerve | - |
dc.subject.other | Neurolysis | - |
dc.subject.other | Conservative treatment | - |
dc.subject.other | Feasibility | - |
dc.title | A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of an internal feasibility pilot study | - |
dc.type | Journal Contribution | - |
dc.identifier.issue | 1 | - |
dc.identifier.volume | 9 | - |
local.format.pages | 11 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Oosterbos, C (corresponding author), KULeuven, Res Grp Expt Neurosurg & Neuroanat, Leuven, Belgium.; Oosterbos, C (corresponding author), Leuven Brain Inst, Leuven, Belgium.; Oosterbos, C (corresponding author), Univ Hosp Leuven, Dept Neurosurg, Leuven, Belgium. | - |
dc.description.notes | christopheoosterbos@gmail.com | - |
local.publisher.place | CAMPUS, 4 CRINAN ST, LONDON N1 9XW, ENGLAND | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
local.bibliographicCitation.artnr | 181 | - |
dc.identifier.doi | 10.1186/s40814-023-01407-x | - |
dc.identifier.pmid | 37908016 | - |
dc.identifier.isi | 001090784000001 | - |
local.provider.type | wosris | - |
local.description.affiliation | [Oosterbos, Christophe; Van Hoylandt, Anais; Hoornaert, Sophie; Theys, Tom] KULeuven, Res Grp Expt Neurosurg & Neuroanat, Leuven, Belgium. | - |
local.description.affiliation | [Oosterbos, Christophe; Van Hoylandt, Anais; Hoornaert, Sophie; Theys, Tom] Leuven Brain Inst, Leuven, Belgium. | - |
local.description.affiliation | [Oosterbos, Christophe; Van Hoylandt, Anais; Hoornaert, Sophie; Theys, Tom] Univ Hosp Leuven, Dept Neurosurg, Leuven, Belgium. | - |
local.description.affiliation | [Rummens, Sofie] Univ Hosp Leuven, Dept Phys Med & Rehabil, Leuven, Belgium. | - |
local.description.affiliation | [Bogaerts, Kris] KULeuven, Dept Publ Hlth & Crit Care, I BioStat, Leuven, Belgium. | - |
local.description.affiliation | [Bogaerts, Kris] UHasselt, I BioStat, Hasselt, Belgium. | - |
local.description.affiliation | [Weyns, Frank] Ziekenhuis Oost Limburg, Dept Neurosurg, Genk, Belgium. | - |
local.description.affiliation | [Weyns, Frank] UHasselt, Fac Med & Life Sci, Neurosci, Hasselt, Belgium. | - |
local.description.affiliation | [Dubuisson, Annie] Univ Hosp Liege, Dept Neurosurg, Liege, Belgium. | - |
local.description.affiliation | [Ceuppens, Jeroen] Algemeen Ziekenhuis Groeninge, Dept Neurosurg, Kortrijk, Belgium. | - |
local.description.affiliation | [Schuind, Sophie] Erasme Univ Hosp, Dept Neurosurg, Brussels, Belgium. | - |
local.description.affiliation | [Groen, Justus L.] Leiden Univ, Leiden Nerve Ctr, Dept Neurosurg, Leiden, Netherlands. | - |
local.description.affiliation | [Lemmens, Robin] KU Leuven Univ Leuven, Dept Neurosci, Expt Neurol, Leuven, Belgium. | - |
local.description.affiliation | [Lemmens, Robin] VIB, Ctr Brain & Dis Res, Lab Neurobiol, Leuven, Belgium. | - |
local.description.affiliation | [Lemmens, Robin] Univ Hosp Leuven, Dept Neurol, Leuven, Belgium. | - |
local.uhasselt.international | no | - |
item.fulltext | With Fulltext | - |
item.accessRights | Open Access | - |
item.contributor | Oosterbos, Christophe | - |
item.contributor | Rummens, Sofie | - |
item.contributor | BOGAERTS, Kris | - |
item.contributor | Van Hoylandt, Anais | - |
item.contributor | Hoornaert, Sophie | - |
item.contributor | WEYNS, Frank | - |
item.contributor | Dubuisson, Annie | - |
item.contributor | Ceuppens, Jeroen | - |
item.contributor | Schuind, Sophie | - |
item.contributor | Groen, Justus L. | - |
item.contributor | Lemmens , Robin | - |
item.contributor | Theys , Tom | - |
item.fullcitation | Oosterbos, Christophe; Rummens, Sofie; BOGAERTS, Kris; Van Hoylandt, Anais; Hoornaert, Sophie; WEYNS, Frank; Dubuisson, Annie; Ceuppens, Jeroen; Schuind, Sophie; Groen, Justus L.; Lemmens , Robin & Theys , Tom (2023) A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment: results of an internal feasibility pilot study. In: Pilot and Feasibility Studies, 9 (1) (Art N° 181). | - |
crisitem.journal.eissn | 2055-5784 | - |
Appears in Collections: | Research publications |
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A randomized controlled trial comparing conservative versus surgical treatment in patients with foot drop due to peroneal nerve entrapment_ results of an internal feasibility pilot study.pdf | Published version | 1.88 MB | Adobe PDF | View/Open |
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