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Behavioural Intervention

Guided Stepping Training for Stroke Recovery (BIG-STEPS Trial)

Q: What are the projected outcomes of this research endeavor?

<p>The primary aim of this research is to observe the modification in Rankin Scale (mRS) over a period of 6 and 12 weeks. Secondary goals include assessing leukoraiosis severity at baseline, administering EuroQol-5D for quality of life survey, and utilizing a six-minute walk test to evaluate endurance levels.</p>

Q: Is there still an opportunity to join this research project?

<p>Evidently, the clinical trial outlined on clinicialtrials.gov is not presently recruiting patients, as it was last edited on June 19th 2023. Despite this fact, 1085 other medical studies are still searching for volunteers at this time.</p>

N/A

Recruiting

Led By Victor Ezeugwu, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk at least 5 meters with/without gait aid

Ongoing walking goals (walk speed <1.0 meter/sec)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

BIG-STEPS Trial Summary

This trial aims to understand how to use imaging and activity info to help improve recovery and mobility after stroke.

Who is the study for?

This trial is for adults who've had an ischemic stroke within the last week. They should be medically stable, able to walk at least 5 meters with or without help, and have goals to improve walking. People with other conditions like MS or Parkinson's, active cancer, uncontrolled high blood pressure, unstable heart issues, or difficulty understanding instructions can't join.Check my eligibility

What is being tested?

The BIG-STEPS intervention aims to reduce sedentary behavior after a stroke to enhance mobility and lessen disability. It involves tracking activity levels using an accelerometer and assessing how brain imaging markers influence rehab outcomes.See study design

What are the potential side effects?

Since this study focuses on behavioral training rather than medication, side effects are not typical as in drug trials but may include fatigue or discomfort from increased physical activity during rehabilitation.

BIG-STEPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk at least 5 meters, with or without help.

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I walk slower than 1 meter per second.

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I am 18 years old or older.

BIG-STEPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

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

+4 more

BIG-STEPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS)Experimental Treatment1 Intervention

Additional to usual care, the experimental arm will undergo a theory-based behaviour change intervention to improve stepping time relative to reducing sedentary behaviour.

Group II: Usual care:Active Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,084 Total Patients Enrolled

24 Trials studying Stroke

2,689 Patients Enrolled for Stroke

Victor Ezeugwu, PhDPrincipal InvestigatorUniversity of Alberta

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05753761 — N/A

Stroke Research Study Groups: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS), Usual care:

Stroke Clinical Trial 2023: Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention Highlights & Side Effects. Trial Name: NCT05753761 — N/A

Behaviour- & Imaging-Guided Stepping Training Early Post-Stroke (BIG STEPS) intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753761 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the projected outcomes of this research endeavor?

"The primary aim of this research is to observe the modification in Rankin Scale (mRS) over a period of 6 and 12 weeks. Secondary goals include assessing leukoraiosis severity at baseline, administering EuroQol-5D for quality of life survey, and utilizing a six-minute walk test to evaluate endurance levels."

Answered by AI

Is there still an opportunity to join this research project?

"Evidently, the clinical trial outlined on clinicialtrials.gov is not presently recruiting patients, as it was last edited on June 19th 2023. Despite this fact, 1085 other medical studies are still searching for volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Whole Day Matters After Stroke (BIG-STEPS)

2023. "The Whole Day Matters After Stroke (BIG-STEPS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753761.