Phase I Split-Belt Treadmill Dosing for Subacute Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Split-Belt Treadmill.
- Who it may be relevant to
- Registry conditions: Subacute Stroke, Stroke, Stroke (Subacute), Stroke Gait Rehabilitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NeuroRecoVR: Phase I Split-Belt Treadmill Dosing for Subacute Stroke
Overview
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.
Interventions
- 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.
Primary outcome measures
- Dose Tolerability [Time frame: 5 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
Canada · 1 center
- Foothills Hospital — Calgary
Identifiers
NCT: NCT07469163 · REB21-1576 Mod4