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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

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ClinicalTrials.gov Identifier: NCT02681146
Recruitment Status : Not yet recruiting
First Posted : February 12, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga

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.


Condition or disease Intervention/treatment Phase
Stroke Other: Multimodal intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : February 2023

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Dr. Antonio I Cuesta-Vargas, Phd, University of Malaga
ClinicalTrials.gov Identifier: NCT02681146     History of Changes
Other Study ID Numbers: UMA
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Antonio I Cuesta-Vargas, University of Malaga:
education
physiotherapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases