Phase I Split-Belt Treadmill Dosing for Subacute Stroke

University of Calgary

Status and phase: Enrolling; Phase 1

Conditions: Stroke; Subacute Stroke; Stroke (Subacute); Stroke Gait Rehabilitation

Treatments: Behavioral: Split-Belt Treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT07469163

REB21-1576 Mod4

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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72 participants in 1 patient group

Intervention - Dose Escalation

Experimental group

Description:

Participants enrolled into split-belt treadmill dose currently being tested

Treatment:

Behavioral: Split-Belt Treadmill