Clinical trial NCT05753761: The Whole Day Matters After Stroke (BIG-STEPS)
Official title: The Whole Day Matters After Stroke: Moving Towards Precision Rehabilitation Guided by Behavioural and Imaging Markers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Movement Behaviors
Leukoaraiosis
Whole Day
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 1 week of ischemic 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.

Detailed description: 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:

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

Methods The investigators aim to recruit 50 participants, within 7 days of ischemic 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.

Eligibility criteria: Inclusion Criteria:

* Within 7 days of ischemic 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.

Primary outcomes:
measure: Change from Baseline modified Rankin Scale (mRS) at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline Timed-Up and Go (TUG) test at 6 and 12 weeks
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Change from Baseline ActivPAL-derived movement behaviors at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline 10-meter walk test at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline 6-minute walk test at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline Montreal Cognitive Assessment (MoCA) at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline EuroQol (EQ)-5D at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Change from Baseline National Institute of Health Stroke Scale (NIHSS) at 6 and 12 weeks
timeFrame: 6 and 12 weeks
measure: Leukoraiosis staging/severity at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Victor Ezeugwu, PhD
role: PRINCIPAL_INVESTIGATOR
References: