A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Malaga
- Primary Endpoint
- Canadian Neurological Scale (CNS):
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Dr. Antonio I Cuesta-Vargas
Phd
University of Malaga
Eligibility Criteria
Inclusion Criteria
- •The study subjects were all patients who had been hospitalised in 8 regional hospitals of Andalusian Health Service with acute cerebral stroke, clinically stable, presented an ischaemic or haemorrhagic aetiology and clinical symptoms of hemiplegia, were selectioned to receiving physiotherapy in hospitalisation, were assisted by a caregiver, had an adequate understanding of Spanish, and had given their written informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Canadian Neurological Scale (CNS):
Time Frame: 8 weeks
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
Secondary Outcomes
- Trunk Control Test (TCT):(8 weeks)
- Barthel Index (BI)(8 weeks)
- Stroke Impact Scale-16 (SIS-16):(8 weeks)
- Modified Rankin Scale (MRS)(8 weeks)
- Motricity index (MI) of the lower and upper limbs(8 weeks)
- Multidimensional Scale of Perceived Social Support (MSPSS)(8 weeks)