Administrative information
Title {1} | Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. |
Trial registration {2a and 2b}. | Limoges University Hospital is the sponsor of this research (Unique Protocol ID: 87RI18_0010). The study protocol was approved by the French Human Subjects Protection Review Board (Comité de Protection des Personnes Nord-Ouest III) on 23 February 2021 (Approval number: 20.12.17.41627). The trial was registered in the ClinicalTrials.gov registry (NCT04800601) on 16 March 2021. |
Protocol version {3} | Version no.2 of 16 February 2021 |
Funding {4} | This research is supported by the French Ministry of Health (PHRC 2020-A03328-31) and is conducted with the support of DGOS (PHRC interregional – GIRCI SOHO). |
Author details {5a} | Béatrice Ferry1, Maxence Compagnat1,2, Jules Yonneau2, Laurent Bensoussan3,4, Geoffroy Moucheboeuf5, François Muller6, Bertrand Laborde6, Anne Jossart7, Romain David7, Julien Magne8, Loïc Marais9 and Jean-Christophe Daviet1,2* Affiliations: * Correspondence: jean-christophe.daviet@unilim.fr 1 Laboratoire HAVAE (UR 20217), EA6310, Université de Limoges, Limoges, France, 2 Médecine Physique et de Réadaptation, CHU Limoges, France, 3 Institut Universitaire de Réadaptation, Marseille, France 4 Médecine Physique et Réadaptation, AP-HM, Marseille, France. 5 Médecine Physique et Réadaptation, CHU Bordeaux, France. 6 Médecine Physique et Réadaptation, Centre Rééducation Les Embruns, Bidart, France. 7 Médecine Physique et Réadaptation, CHU Poitiers, France. 8 Centre d’Epidémiologie de Biostatistiques et Méthodologie de la Recherche, CHU Limoges, France. 9 Direction de la Recherche et de l’Innovation, CHU Limoges, France |
Name and contact information for the trial sponsor {5b} | Limoges University Hospital, 2 avenue Martin Luther King 87042 Limoges Cedex |
Role of sponsor {5c} | The sponsor has taken the initiative for a clinical trial and assumes the responsibilities and funding for this latter. In practice, the sponsor is responsible for the entire organisation, implementation and monitoring of the clinical trial: choosing the investigator, ensuring data management and carrying out quality controls, obtaining the favourable opinion of the human subjects’ protection review board and the authorisation of the competent authority, taking out insurance and declaring to the competent authority any undesirable events that occur during the research. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: Participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Outcome measurements
Participant timeline {13}
Inclusion
Randomisation
Follow-up
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: Blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Primary endpoint analysis
The following secondary endpoint analyses:
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The comparison of the mean difference of the SIPSO score between 6 months and 1 year (T12M – T6M) will be performed by means of a Student's t test if the variable follows a normal distribution (Shapiro-Wilks test) or by a non-parametric Mann-Whitney test otherwise.
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The comparison of the progression of the 4 spatiotemporal parameters selected (duration of the stance and swing phases, step cadence and variability) will be performed using a mixed generalised linear regression.
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The comparison of the progression of the 2 parameters describing the force of the dorsi-flexor muscles (peak torque in Nm and active amplitude in degrees) will be performed using a generalised linear regression.
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The comparison of the proportion of patients who used a technical aid will be performed by a Pearson’s chi [2] test or a Fisher’s exact test if at least one theoretical number is <5). The comparison of the number of falls per patient after 6 months will be performed by a binomial negative regression.
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Correlations between [1] dorsi-flexor muscle strength (2 parameters) and walking speed at 6 weeks, 6 months, and 1 year [2]; dorsi-flexor muscle strength (2 parameters) and SIPSO score at 6 months and 1 year [3]; walking speed and SIPSO score at 6 months and 1 year will be performed using the Pearson or Spearman correlation coefficient test depending on the conditions of application.
Interim analyses {21b}
Methods for additional analyses (e.g. subgroup analyses) {20b}
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Plans to give access to the full protocol, participant level-data and statistical code {31c}
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
Composition of the data monitoring committee, its role and reporting structure {21a}
Adverse event reporting and harms {22}
Frequency and plans for auditing trial conduct {23}
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Dissemination plans {31a}
Discussion
Trial status
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Version 2: February 2, 2021
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Overall status: recruitment in progress.
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Study start: May 20, 2021
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Recruitment end date: November 20, 2022
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Study end: November 20, 2023