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

Not yet recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Multimodal intervention Other
    Intervention Desc: Educational advice + physiotherapist treatment
    ARM 1: Kind: Experimental
    Label: Group1
    ARM 2: Kind: Experimental
    Label: Group2
    ARM 3: Kind: Experimental
    Label: Group3
    ARM 4: Kind: Experimental
    Label: Group4
    ARM 5: Kind: Experimental
    Label: Group5
    ARM 6: Kind: Experimental
    Label: Group6
    ARM 7: Kind: Experimental
    Label: Group7
    ARM 8: Kind: Experimental
    Label: Group8

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Canadian Neurological Scale (CNS): 8 weeks Yes
Secondary Trunk Control Test (TCT): 8 weeks Yes
Secondary Motricity index (MI) of the lower and upper limbs 8 weeks Yes
Secondary Barthel Index (BI) 8 weeks Yes
Secondary Stroke Impact Scale-16 (SIS-16): 8 weeks Yes
Secondary Modified Rankin Scale (MRS) 8 weeks Yes
Secondary Multidimensional Scale of Perceived Social Support (MSPSS) 8 weeks Yes

Sponsors