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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Contact Information
Primary
Victor Ezeugwu, PhD
ezeugwu@ualberta.ca
7804925108
Time Frame
Start Date: 2023-07-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
Experimental: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS)
Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour.
Active_comparator: Usual care:
The control arm program will consist of usual inpatient care including therapeutic mobilization by the physical therapy team and general mobilization, as tolerated, by the nursing team.
Related Therapeutic Areas
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov