Phase I Split-Belt Treadmill Dosing for Subacute Stroke

NCT07469163 | Recruiting Phase 1 DMC

• 1 other identifier: REB21-1576 Mod4
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subacute Stroke; Stroke; Stroke (Subacute); Stroke Gait Rehabilitation

Keywords

stroke; subacute stroke; split belt treadmill; gait rehabilitation; stroke recovery

Outcome Measures

Primary Outcomes (1)

• Dose Tolerability

  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

Study Arms (1)

Intervention - Dose Escalation

EXPERIMENTAL

Participants enrolled into split-belt treadmill dose currently being tested

Behavioral: Split-Belt Treadmill

Interventions

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.

Intervention - Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N2T9, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Alexa Boyer

CONTACT

5193594643; alexa.boyer1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a Phase I dose-ranging trial utilizing a rule-based A+B design. The primary goal of this investigation is to employ a dose escalation paradigm to ascertain the maximum tolerated dose of split-belt walking in a day. For each investigated dose, three participants (A) are recruited. If all participants tolerate the dose, three more participants (A) are recruited and enrolled at the next available dose. If dose limiting criteria is met for one of the three participants (A), three more participants (B) are recruited and enrolled at the current dose.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CA (1)