NCT02681146

A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A stepped-wedge cluster design will be used, with the duration of the trial being 50 weeks. The 'stepped-wedge ' cluster randomised trial is a form of cross-over design with unidirectional cross-over ( from control to experimental ) but with randomisation of when each cluster undertakes this transition. In the stepped-wedge design, there is a staggered roll-out of the intervention, where the time and hence the sequence of units (clusters) that will start the intervention at each period is determined by random allocation. The randomisation occurs before the start of the trial. All clusters start the trial in a control phase with no intervention being delivered at any site, then sequentially cross over from the control group to the intervention group, until all sites are receiving the intervention. Outcomes are measured on the study participants in all clusters at every time period, hence measurement of outcomes takes place at each step in the wedge; each cluster provides data points in the control and intervention conditions allowing each site to act as its own control.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Multimodal intervention	Educational advice + physiotherapist treatment

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-01-01
• Completion: 2025-06-01
• First posted: 2016-02-12
• Last updated: 2024-06-04