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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: Multimodal intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group2<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group3<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group4<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group5<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group6<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group7<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|
| Experimental: Group8<br>Educational advice + physiotherapist treatment | Other: Multimodal intervention<br>* Educational advice + physiotherapist treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk Control Test (TCT): | scores trunk control (psychometric properties: inter-rater reliability by Spearman's correlation coefficient r=0.76; internal consistency by Cronbach's alpha 0.83-0.86). | 8 weeks | 
| Motricity index (MI) of the lower and upper limbs | measures upper and lower limb strength (Spearman's correlation coefficient of 0.87 (p<0.001) for MI-LL, and of 0.88 (p<0.001) for MI-UL). | 8 weeks | 
| Barthel Index (BI) | scores the patient's ability to perform activities of daily living (ADL) (inter-observer reliability by Kappa indices 0.47-1.00; intra-observer reliability by Kappa indices 0.84-0.972; internal consistency by Cronbach's alpha 0.86-0.92). | 8 weeks | 
| Stroke Impact Scale-16 (SIS-16): | measures the deficits and physical limitations provoked by stroke (ADL, mobility and hand function) (internal consistency by Cronbach's alpha 0.87-0.95). | 8 weeks | 
| Modified Rankin Scale (MRS) | to score the incapacity of the patient (inter-observer reliability by Kappa indices (k=0.56 to k=0.78). Good test-re-test reliability (k=0.81 to k=0.95). | 8 weeks | 
| Multidimensional Scale of Perceived Social Support (MSPSS) |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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education, physiotherapy