Subacute StrokePhase 1NCT07469163
Phase I Split-Belt Treadmill Dosing for Subacute Stroke
A Phase 1 study testing Split-Belt Treadmill in people with Subacute Stroke and Stroke, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Stroke, Stroke, Stroke (Subacute)
- What is being tested?
- Split-Belt Treadmill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke survivors
- First stroke
- Over 18 years old
- Between one week and three months post-stroke
- can understand task instructions.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Foothills Hospital
Calgary, Alberta, T2N2T9
Sean Dukelow, MD PhD, 4039445930, spdukelo@ucalgary.ca
About this study
Official title: 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.
- Conditions
- Subacute Stroke, Stroke, Stroke (Subacute), Stroke Gait Rehabilitation
- Being tested
- Split-Belt Treadmill
- Keywords
- stroke, subacute stroke, split belt treadmill, gait rehabilitation, stroke recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-Belt TreadmillBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Dose Escalation | Experimental | Participants enrolled into split-belt treadmill dose currently being tested Receives: Behavioral: Split-Belt Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sean Dukelow, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469163
- Sponsor's protocol ID
- REB21-1576 Mod4
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroRecoVR: Phase I Split-Belt Treadmill Dosing for Subacute Stroke
- ClinicalTrials.gov ID
- NCT07469163
- Acronym / sponsor ID
- REB21-1576 Mod4
- Conditions
- Subacute Stroke, Stroke, Stroke (Subacute), Stroke Gait Rehabilitation
- Keywords
- stroke, subacute stroke, split belt treadmill, gait rehabilitation, stroke recovery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Dose Escalation | Experimental | Behavioral: Split-Belt TreadmillParticipants enrolled into split-belt treadmill dose currently being tested |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic or hemorrhagic stroke survivors
- First stroke
- Over 18 years old
- Between one week and three months post-stroke
- can understand task instructions.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Split-Belt TreadmillParticipants 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. | Behavioural | Intervention - Dose Escalation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Split-Belt Treadmill in people with Subacute Stroke and Stroke, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexa Boyer (5193594643, alexa.boyer1@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Tolerability (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.