Phase I Split-Belt Treadmill Dosing for Subacute Stroke

March 9, 2026 updated by: Dr. Sean Dukelow, University of Calgary

NeuroRecoVR: Phase I Split-Belt Treadmill Dosing for Subacute Stroke

After experiencing a stroke, many individuals encounter difficulties with walking and balance, which can significantly impact their independence. Recent studies have indicated that split-belt treadmill (SBT) training is effective for improving gait metrics, including walking speed and step length asymmetry. The SBT allows each leg to move at different speeds, which has been shown to help chronic stroke survivors learn to walk more symmetrically. However, there is limited knowledge about the dose participants should receive and the safety of SBT training in the early stages of recovery, which is a crucial period for rehabilitation. To address this gap, we are evaluating an innovative SBT with virtual reality (VR) features at the Foothills Medical Center. Our objective is to conduct a study to determine the amount of SBT training patients can tolerate in a day. In this study, stroke survivors will engage in a series of walking exercises on the SBT. We will escalate the duration of SBT walking until participants reach a point where they can no longer continue due to dose-limiting criteria such as fatigue or discomfort. The findings from this initial phase will guide future larger trials to explore the effectiveness of this training method. Ultimately, we aspire to improve rehabilitation strategies for stroke survivors, assisting them in regaining mobility and enhancing their quality of life more effectively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Recruiting
        • Foothills Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke survivors
  • First stroke
  • Over 18 years old
  • Between one week and three months post-stroke
  • can understand task instructions.

Exclusion Criteria:

  • History of significant neurological diseases (e.g. Multiple Sclerosis, Parkinson's disease)
  • Orthopedic issues in lower extremities (e.g. severe knee Osteoarthritis)
  • Excessive pain preventing participants from participating in treadmill-based activities
  • Cerebellar stroke
  • Body weight more than 560 lbs (this exceeds the weight limit of the support harness)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - Dose Escalation
Participants enrolled into split-belt treadmill dose currently being tested
Behavioral: Split-Belt Treadmill
Participants undertake 5 days of treadmill walking. Each day is broken into 3 episodes: A) two-minutes tied-belt walking, B) n minutes split-belt walking (dose escalating component), C) 10-minutes tied-belt walking. Split-belt walking will start at a dose of 8-minutes and escalate by 3 minute increments, up to a maximum dose of 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Tolerability
Time Frame: 5 days

Dose tolerability, defined as the presence, or lack thereof, any of the following dose-limiting criteria:

  • Participant requests to stop/declines to participate in any more sessions during the intervention period
  • Participant requests to stop before completing ≥80% of a session, 2+ times during the intervention period, for an intervention-related reason
  • Unfeasible to deliver ≥80% of a session, two or more times during the intervention period for organizational or environmental constraints
  • Unable to complete activities of their daily routine within 24 hours after their session
  • Therapist requests to stop before completing ≥80% of a single session 1+ times during the intervention period due to therapist fatigue
  • Participants cannot ramp up to the intended dose level within 3 days.
  • The therapist requests to stop before completing ≥80% of a single session 1+ times during the intervention period due to poor walking quality
  • Participant experiences attributable adverse event
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB21-1576 Mod4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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