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Completed

NCT Number: NCT05753761

The Whole Day Matters After Stroke (BIG-STEPS)

Goal of research program: To understand person-specific factors, such as imaging markers and activity patterns early after stroke, that may guide precision rehabilitation to optimize function and improve recovery.

Objectives:

1. Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes. 2. Determine the impact of neuroimaging biomarkers (e.g. leukoaraiosis) on response to rehabilitation. 3. Explore the predictive value of accelerometry as an adjunct to the subjective modified Rankin Scale (mRS) to assess functional disability after stroke.

Experimental approach/Research Plan/Use of Funds: The investigators aim to recruit 50 participants within 3 months of stroke onset, aged ≥ 18 years, medically stable as deemed by their physicians, able to walk at least 5 meters with/without gait aid and with ongoing walking or balance goals. Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on routine MRI, and acute stroke treatments (e.g., thrombectomy) will be determined and documented. A battery of impairment, psychosocial, and functional measures, including the mRS and Timed-Up and Go test (primary outcomes) will be completed. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke, for 1 week. Following randomization, a sedentary behaviour change intervention will span 6 weeks, with final follow-up assessments at 90 days.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

About this study

Background Prolonged sedentary behaviour is associated with worse functional outcomes poststroke. The effect of reducing sedentary behaviour early after stroke remains unknown. Leukoaraiosis or cerebral white matter disease, recognizable on magnetic resonance imaging (MRI) as areas of hyperintensities, has gained significance as a potential moderator of stroke recovery. No specific rehabilitation intervention has been developed for survivors of stroke with leukoaraiosis.

The goals of this research project are to:

  • Test the effect of reducing sedentary behaviour early after stroke on functional mobility and global disability outcomes.
  • Determine the impact of leukoaraiosis on response to poststroke rehabilitation.
  • Explore the associations of accelerometry metrics with functional mobility and global disability outcomes poststroke.

Methods The investigators aim to recruit 50 participants, within 3 months of stroke onset, aged ≥ 18 years, medically stable as deemed by physicians, able to walk at least 5 meters with/without gait aid, and ongoing walking goals (walk speed <1.0 meter/second). Demographic and stroke characteristics, including stroke risk factors, infarct location and volume, leukoaraiosis on MRI, and acute stroke treatments (e.g. thrombectomy) will be determined and documented. Subsequently, participants will be set up to wear activPAL accelerometer, validated in stroke,5 for one week. Following randomization, a behaviour change intervention will span 6 weeks with final follow-up assessments at 90 days.

Primary outcomes: modified Rankin Scale and Timed-Up and Go (TUG) score.

Plan for Data Analysis Compositional data analysis and generalized estimating equations with R software will be used to model the effect of reducing sedentary behaviour and impact of leukoaraiosis on response to rehabilitation. The correlation, responsiveness, and predictive value of the activPAL outcomes as adjunct to the mRS and TUG measures will be evaluated using machine learning, logistic regression, and receiver operating curves.

Significance and Expected Results The first 90 days after stroke represents a critical window of neuroplasticity. Frequent interruptions in sedentary behaviour, using a whole-day approach, may improve function and recovery, especially for poor responders. If the investigators find this rehabilitation approach to be effective for survivors of stroke with leukoaraiosis, then it could be useful for improving decision-making. Accelerometry as an adjunct to the MRS will increase the granularity of outcome measurement poststroke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Within 3 months of stroke onset
  • Aged ≥ 18 years
  • Medically stable as deemed by physicians
  • Able to walk at least 5 meters with/without gait aid
  • Ongoing walking goals (walk speed <1.0 meter/sec)

Exclusion criteria

  • Have another condition such as multiple sclerosis or Parkinson's disease, or active cancer
  • Uncontrolled high blood pressure
  • Unstable cardiovascular condition
  • Unable to understand or follow instructions.

Treatment and study plan

Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention

Behavioral

Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed.

Primary outcomes

  1. Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    Measure of global disability using the mRS score [grade 0-2 vs ≥3]

  2. Change from Baseline Timed-Up and Go (TUG) test at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    Functional mobility will be assessed using the TUG test

Secondary outcomes

  1. Change from Baseline ActivPAL-derived movement behaviors at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    Whole-day movement behaviours (time spent stepping, sedentary, sleeping, number of steps, and sit-to-stand transitions)

  2. Change from Baseline 10-meter walk test at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    Measure of gait speed

  3. Change from Baseline 6-minute walk test at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    6-minute walk test of endurance

  4. Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    Montreal Cognitive Assessment (MoCA) test of cognition

  5. Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    EQ-5D to assess quality of life

  6. Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks

    Time frame: 6 and 12 weeks

    NIHSS to classify stroke severity

  7. Leukoraiosis staging/severity at Baseline

    Time frame: Baseline

    White matter disease on imaging

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers

Acronym: BIG-STEPS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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