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

University of Malaga

Status: Withdrawn

Conditions: Stroke

Treatments: Other: Multimodal intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02681146

UMA

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 8 patient groups

Group1

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group2

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group3

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group4

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group5

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group6

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group7

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention

Group8

Experimental group

Description:

Educational advice + physiotherapist treatment

Treatment:

Other: Multimodal intervention