NCT06850662

Brief Summary

Walking impairment is one of the most common and concerning issues for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for gait performance progress in individuals with stroke. However, for people with chronic stroke, it may be more appropriate to prioritize improving gait symmetry and gait variability to enhance gait quality as a primary intervention goal. Additionally, stroke can lead to an imbalance in interhemispheric brain activity, which evolves as motor function recovers. According to the literature review, backward walking may extend the support time of the lower limbs, thereby enhancing the weight-bearing capacity of the affected limb. This, in turn, could promote gait symmetry and reduce gait variability. Changes in brain activity might also accompany such improvements in gait quality. Therefore, this study aims to investigate the immediate, short-term and post carryover intervention effects of backward walking observation training on gait quality in individuals with chronic stroke as well as to explore its effects on interhemispheric activity balance in individuals with chronic stroke.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
29mo left

Started Apr 2025

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
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

Study Progress31%
Apr 2025Sep 2028

First Submitted

Initial submission to the registry

February 17, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

February 17, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Backward walkingAction observation trainingGait symmetryGait variabilityBrain activityStroke

Outcome Measures

Primary Outcomes (3)

  • Brain activity

    Using functional near infrared spectroscopy to measure the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the bilateral prefrontal cortex, supplementary motor area and primary motor cortex.

    Baseline, 4 weeks after training, and 4-week follow-up

  • Gait symmetry

    Using GAITRite system to measure the symmetry of spatiotemporal parameters

    Baseline, post-intervention, 4 weeks after training, and 4-week follow-up

  • Gait varability

    Using GAITRite system to measure the coefficient of variation of spatiotemporal parameters

    Baseline, post-intervention, 4 weeks after training, and 4-week follow-up

Secondary Outcomes (4)

  • Gait performance

    Baseline, post-intervention, 4 weeks after training, and 4-week follow-up

  • Time Up & Go test

    Baseline, 4 weeks after training, and 4-week follow-up

  • Activities-specific Balance Confidence Scale

    Baseline, 4 weeks after training, and 4-week follow-up

  • Taiwan Chinese version Falls Efficacy Scale

    Baseline, 4 weeks after training, and 4-week follow-up

Study Arms (2)

Backward walking observation training group

EXPERIMENTAL

The intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks.

Other: Backward walking observation training

Non-motor observational backward walking training group

ACTIVE COMPARATOR

The intervention is a 50-minute session and 3 sessions/week, totaling 4 weeks.

Other: Non-motor observational backward walking training

Interventions

Backward treadmill training after watching a video of backward walking.

Backward walking observation training group

Backward treadmill training after watching a video of landscape without any movements.

Non-motor observational backward walking training group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 6 months after the diagnosis of stroke
  • Independent walking over at least 7m with or without a walking aid
  • Mini-mental state examination score ≥ 24

You may not qualify if:

  • Had difficulty in backward walking
  • Any neuromuscular disorders history
  • With visual or auditory disorders
  • Unstable cardiac status or uncontrolled hypertension
  • Any musculoskeletal disorders that would affect walking ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Yea-Ru Yang, PhD

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
Professor

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 27, 2025

Study Start

April 24, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations