NCT07601633

Brief Summary

Stroke is a leading cause of long-term disability in adults. Although many individuals regain independent walking ability following stroke, nearly 50% experience persistent gait impairments characterized by asymmetrical walking patterns, slower walking speed, impaired balance, and increased fall risk. These persistent mobility limitations highlight the continued need for innovative rehabilitation strategies that improve gait function during stroke recovery. Split-belt treadmill walking (SBTW), in which each leg walks at a different belt speed, has demonstrated potential to improve step length symmetry in individuals with chronic stroke. However, the effects of SBTW during the subacute stage of stroke recovery, within the first 9 months post-stroke when neuroplasticity may be heightened, remain largely unknown. In addition, previous SBTW studies have not integrated active physiotherapist-led gait retraining into the intervention, despite physiotherapist-led gait rehabilitation representing standard clinical care following stroke. The purpose of this randomized controlled trial is to compare physiotherapist-led gait retraining using a traditional treadmill training protocol to physiotherapist-led gait retraining integrated with a split-belt treadmill training protocol during the first 9 months post-stroke. The study aims to examine the effectiveness of the use of split-belt treadmill training to augment physiotherapist-led gait retraining to improve between-leg gait symmetry and overground walking speed.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
38mo left

Started Jun 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

May 15, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

split-belt walking

Outcome Measures

Primary Outcomes (2)

  • Step length symmetry

    Baseline, immediately post-intervention, and at 1-month follow-up

  • Self-selected gait speeds

    Self-selected gait speeds at both comfortable and fast speed will be measured by overground 10 meter walk tests

    Baseline, immediately post-intervention, and at 1-month follow-up

Study Arms (2)

Split-belt treadmill training

EXPERIMENTAL

Participants will complete 12 gait training sessions over 4 weeks (3 sessions/week) on an instrumented split-belt treadmill involving both split-belt and tied-belt walking conditions. A physiotherapist will provide gait retraining during each training session.

Behavioral: Split-belt walking training

Traditional treadmill training

NO INTERVENTION

Participants will complete 12 gait training sessions over 4 weeks (3 sessions/week) on an instrumented treadmill under tied-belt walking conditions only. A physiotherapist will provide gait retraining during each training session.

Interventions

Participants randomized to the split-belt training group will complete 12 sessions of split-belt treadmill walking training over 4 weeks, delivered 3 times per week. Training will be performed on an instrumented split-belt treadmill and will include split-belt and tied-belt walking conditions. A physiotherapist will provide gait retraining during each session.

Split-belt treadmill training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral stroke resulting in hemiparesis
  • less than 9 months post-stroke
  • ability to walk ten metres with or without walking aids
  • ability to stand without support for five minutes
  • English speaking

You may not qualify if:

  • medically unfit to participate e.g. cardiac or respiratory disease limiting ability to perform walking tasks
  • neuromuscular impairment, other than stroke, limiting mobility, e.g. ankle sprain, joint disease such as severe arthritis
  • cognitive/communication impairment impacting ability to follow instructions
  • diagnosis of clinical depression or anxiety disorders requiring medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Courtney Pollock, PT PhD

CONTACT

Beier Lin

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 3 months and ending 3 years after the publication of results
Access Criteria
The PI will accept a proposal that describes planned analyses and assess the need for a data sharing agreement.

Locations