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Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS)

3 september 2026 bijgewerkt door: University of Alberta

Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.

Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.

The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.

Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.

The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.

The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Nog niet aan het werven
        • Foothills Medical Center
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Victor Ezeugwu, PhD
      • Calgary, Alberta, Canada, T2E 6V7
        • Nog niet aan het werven
        • Carewest Dr Vernon Fanning Centre
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T6G 2B7
        • Werving
        • University of Alberta Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T5H 3V9
        • Werving
        • Royal Alexandra Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T6L 5X8
        • Werving
        • Grey Nuns Community Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T5G 0B7
        • Werving
        • Glenrose Rehabilitation Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Victor Ezeugwu, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Aged 50 - or older
  • Had an ischemic or hemorrhagic stroke within the last 3 months
  • Have recently returned or are returning home from hospital
  • Able to walk 5 meters with or without a gait aid

Exclusion Criteria:

  • Previously diagnosed with a mobility limiting musculoskeletal condition
  • Previously diagnosed with a mobility limiting neurological condition
  • Have cardiac conditions (e.g. blood pressure ≥180/100 mmHg)
  • Are without access to an internet-enabled computer or mobile device
  • Are enrolled in another interventional trial such as exercise or neuroprotection trials
  • Have aphasia or are unable to provide consent in English.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Early BIG STEPS
Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. Participants will start the BIG STEP intervention within 3 months of stroke onset.
Gedragsmatig: Behavior and guided stepping training intervention (BIG STEPS)
The BIG STEPS intervention comprises a home-based behavioral intervention aimed at reducing and frequently interrupting prolonged sedentary periods, along with guided stepping training to gradually increase daily steps. Participants will wear an accelerometer throughout the whole day for four consecutive days during each assessment. Using baseline accelerometer data, prolonged periods of sedentary time or minimal activity levels will be identified and used to inform personalized activity and behavior-change recommendations.
Ander: Delayed BIG STEPS
The waitlist control group will complete the BIG STEPS intervention after 6 months.
Gedragsmatig: DELAYED Behavior and guided stepping training intervention
The waitlist control group will complete the BIG STEPS intervention after 6 months. During the waiting period they will receive usual care and educational materials.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Physical functioning: Step Counts
Tijdsspanne: Difference in changes from baseline to 3 months (post intervention/post waiting)
activPAL derived step counts
Difference in changes from baseline to 3 months (post intervention/post waiting)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sedentary time
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
activPAL-derived sedentary time.
Change from baseline at 3, 6, 9 and 12 months.
Global Disability
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome.
Change from baseline at 3, 6, 9 and 12 months.
Functional mobility
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Timed Up and Go Test (TUG)
Change from baseline at 3, 6, 9 and 12 months.
Gait Speed
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
10-meter walk test (10MWT)
Change from baseline at 3, 6, 9 and 12 months.
Walking Endurance
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
6-Minute walk test (6MWT)
Change from baseline at 3, 6, 9 and 12 months.
Self efficacy
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Stroke Self Efficacy Questionnaire is a 13-item questionnaire. Higher scores in each subscale indicate higher confidence levels and better self-efficacy.
Change from baseline at 3, 6, 9 and 12 months.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Stanford Gender-Related Variables for Health Research scale
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
The Stanford Gender-Related Variables for Health Research scale is a 25-item self-report survey that measures how specific gender-related behaviors and roles impact physical and mental well-being.
Change from baseline at 3, 6, 9 and 12 months.
Cognition
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
5-minute Montreal Cognitive Assessment (5-min MoCA)
Change from baseline at 3, 6, 9 and 12 months.
Memory
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Multifactorial Memory Questionnaire 9 (MMQ-9). T scores will be derived. T scores between 40 and 60 are generally interpreted as average.
Change from baseline at 3, 6, 9 and 12 months.
EuroQol-5 Dimension 5-Level (EQ-5D-5L)
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
The 5-level EQ-5D version (EQ-5D-5L) is a patient-reported quality of life measure. Country-specific valuation set will be used. The EQ-5D VAS score rates perceived health on a scale of 0-100, where higher scores are better.
Change from baseline at 3, 6, 9 and 12 months.
Depression
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire where higher scores represent worse outcome.
Change from baseline at 3, 6, 9 and 12 months.
Fatigue Severity Scale (FSS)
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Fatigue Severity Scale (FSS) is a 9-item questionnaire with higher scores indicating worse outcome
Change from baseline at 3, 6, 9 and 12 months.
Pittsburgh Sleep Quality Index (PSQI)
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Pittsburgh Sleep Quality Index (PSQI) scores range from 0 to 21 where higher scores are worse.
Change from baseline at 3, 6, 9 and 12 months.
Modified Caregiver Stress Index
Tijdsspanne: Change from baseline at 3, 6, 9 and 12 months.
Modified Caregiver Stress Index is a 13-item questionnaire with higher scores indicating greater caregiver burden.
Change from baseline at 3, 6, 9 and 12 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Alberta

Medewerkers

Canadian Institutes of Health Research (CIHR)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 augustus 2026

Primaire voltooiing (Geschat)

30 juni 2030

Studie voltooiing (Geschat)

30 juni 2031

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2026

Laatste update ingediend die voldeed aan QC-criteria

3 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Pro00140017

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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