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NCT Number: NCT07469163

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.

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Key information

Conditions

Subacute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Stroke (Subacute) Stroke Gait Rehabilitation Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Foothills Hospital

Calgary, Alberta, T2N2T9, Canada

Location status: Recruiting

Location contact

Sean Dukelow, MD PhD

CONTACT

[email protected]

4039445930

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Split-belt Treadmill

Behavioral

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa Boyer

CONTACT

[email protected]

5193594643

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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