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

June 2, 2024 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk Control Test (TCT):
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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):
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimated)

February 12, 2016

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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