StrokeNCT02681146
A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment
A study testing Multimodal intervention in people with Stroke, run by University of Malaga.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Multimodal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
- Conditions
- Stroke
- Being tested
- Multimodal intervention
- Keywords
- education, physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal interventionOther
Educational advice + physiotherapist treatment
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group2 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group3 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group4 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group5 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group6 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group7 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
| Group8 | Experimental | Educational advice + physiotherapist treatment Receives: Other: Multimodal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: No funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681146
- Sponsor's protocol ID
- UMA
- Status last verified
- Jun 2024
- First submitted
- 9 Feb 2016
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment
- ClinicalTrials.gov ID
- NCT02681146
- Acronym / sponsor ID
- UMA
- Conditions
- Stroke
- Keywords
- education, physiotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group2 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group3 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group4 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group5 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group6 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group7 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
| Group8 | Experimental | Other: Multimodal interventionEducational advice + physiotherapist treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal interventionEducational advice + physiotherapist treatment | Other | Group1, Group2, Group3, Group4, Group5, Group6, Group7, Group8 |
Primary outcome
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
6 secondary outcomes
Trunk Control Test (TCT):
Time frame: 8 weeks
Motricity index (MI) of the lower and upper limbs
Time frame: 8 weeks
Barthel Index (BI)
Time frame: 8 weeks
Stroke Impact Scale-16 (SIS-16):
Time frame: 8 weeks
Modified Rankin Scale (MRS)
Time frame: 8 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention in people with Stroke, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Neurological Scale (CNS): (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.