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

3 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

150

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Pas encore de recrutement
        • Foothills Medical Center
        • Contact:
        • Contact:
        • Chercheur principal:
          • Victor Ezeugwu, PhD
      • Calgary, Alberta, Canada, T2E 6V7
        • Pas encore de recrutement
        • Carewest Dr Vernon Fanning Centre
        • Contact:
        • Contact:
        • Chercheur principal:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recrutement
        • University of Alberta Hospital
        • Contact:
        • Contact:
        • Chercheur principal:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T5H 3V9
        • Recrutement
        • Royal Alexandra Hospital
        • Contact:
        • Contact:
        • Chercheur principal:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T6L 5X8
        • Recrutement
        • Grey Nuns Community Hospital
        • Contact:
        • Contact:
        • Chercheur principal:
          • Victor Ezeugwu, PhD
      • Edmonton, Alberta, Canada, T5G 0B7
        • Recrutement
        • Glenrose Rehabilitation Hospital
        • Contact:
        • Contact:
        • Chercheur principal:
          • Victor Ezeugwu, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.
Autre: Delayed BIG STEPS
The waitlist control group will complete the BIG STEPS intervention after 6 months.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Physical functioning: Step Counts
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Sedentary time
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Stanford Gender-Related Variables for Health Research scale
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Alberta

Collaborateurs

Canadian Institutes of Health Research (CIHR)

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

3 août 2026

Achèvement primaire (Estimé)

30 juin 2030

Achèvement de l'étude (Estimé)

30 juin 2031

Dates d'inscription aux études

Première soumission

3 juillet 2026

Première soumission répondant aux critères de contrôle qualité

8 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Pro00140017

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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