Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Jan 2020

Longer than P75 for not_applicable stroke

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

First Submitted

Initial submission to the registry

February 9, 2016

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed

3.9 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed

Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

5 years

First QC Date

February 9, 2016

Last Update Submit

June 2, 2024

Conditions

Stroke

Keywords

educationphysiotherapy

Outcome Measures

Primary Outcomes (1)

Canadian Neurological Scale (CNS):
Measures neurological status of stroke (psychometric properties: Spearman correlation coefficient of 0.924 (95% CI: 0.896-0.951) and internal consistency by Cronbach's alpha of 0.792, N=155
8 weeks

Secondary Outcomes (6)

Trunk Control Test (TCT):
8 weeks
Motricity index (MI) of the lower and upper limbs
8 weeks
Barthel Index (BI)
8 weeks
Stroke Impact Scale-16 (SIS-16):
8 weeks
Modified Rankin Scale (MRS)
8 weeks
+1 more secondary outcomes