Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke

NCT06972355 | Recruiting

• 1 other identifier: 2025-01-CHRMT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of this study is to compare the efficiency of vision-obscured versus vision-retained treadmill gait training in subacute post-stroke patients. Methodology: Thirty-six patients with stroke (ischemic or hemorrhagic) less than six months old will be included and randomized into two parallel groups. The experimental group will undergo treadmill gait training using an opaque mask, combined with body weight reduction (Lite Gait® harness). The control group will follow the same walking protocol, but with their eyes open. Each session will last 20 minutes, integrated into one hour of rehabilitation, at a rate of three sessions per week for six weeks. Assessment will include single- and double-task walking speed, balance parameters and proprioception. Expected results: The hypothesis is that visual deprivation will stimulate the proprioceptive and vestibular systems to a greater extent, resulting in benefits for postural balance, walking and proprioception. The main hypothesis will be the improvement in the difference between single-task and double-task walking speed. Analyses will be conducted on an intention-to-treat basis, using statistical tests adapted to the nature of the variables. Conclusion: This study could highlight the value of temporary visual suppression as a therapeutic lever in stroke rehabilitation.

Conditions

Subacute Stroke

Keywords

Stroke; Gait; Treadmill; Double task; Proprioception; Postural balance

Outcome Measures

Primary Outcomes (1)

• Dual-task walking speed assessment

  Speed (m/s) The dual-task walking speed assessment measures how well a person walks while simultaneously performing a cognitive or motor task. It helps identify changes in gait speed and stability when attention is divided, revealing potential fall risk or cognitive-motor interference.

  6 weeks after subacute stroke

Secondary Outcomes (9)

• Gait Speed assessment

  3 to 6 monts after subacute stroke

• Average step duration evaluation

  3 to 6 monts after subacute stroke

• Gait symmetry evaluation

  3 to 6 monts after subacute stroke

• Cycle duration variability evaluation

  3 to 6 monts after subacute stroke

• Single-task and double-task gait speed evaluation

  3 to 6 monts after subacute stroke

Study Arms (2)

Hidden Eyes

EXPERIMENTAL

Treadmill walking training with body weight reduced and eyes hidden

Procedure: Hiding the eyes

Open Eyes

NO INTERVENTION

Treadmill walking training with reduced body weight and open eyes.

Interventions

Hiding the eyes PROCEDURE

Patients will participate in walking rehabilitation sessions on a treadmill supported by a Lite Gait® harness. All treadmill sessions are consistent with regular rehabilitation sessions. A typical treadmill walking session will take place 3 times a week for 6 weeks, lasting 20 minutes. During the first minute, the speed of the treadmill is gradually increased until a comfortable speed is reached. From then on, the mask will be placed over the patient's eyes for 18 minutes at a constant, i.e. comfortable, speed. The last minute will be devoted to gradually decreasing the treadmill speed until it stops, and will also be performed without the mask.

Hidden Eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older,
• With a confirmed diagnosis of ischemic or hemorrhagic stroke in sub-acute phase (stroke less than 6 months old),
• With NIHSS scores between 1 and 15 and MoCA scores between 18 and 30
• With a physiotherapy prescription for post Stroke rehabilitation
• Able to walk for 20 min on a treadmill with weight reduction with pauses, able to maintain bipodal balance, able to maintain bipodal balance with eyes open and closed for 30 seconds,
• Having expressed free, informed and written consent
• Affiliated with a social security scheme.

You may not qualify if:

• Patients weighing over 200 kg (maximum weight permitted for use of the Lite Gait ®),
• Patients with impaired vision:
• Best corrected visual acuity below 5/10 on patient examination
• Homonymous lateral hemianopia, quadranopia.
• Inability to physically participate in intensive rehabilitation due to severe, unstabilized and comorbidities (heart, lung, kidney disease or diabetes), severe psychiatric disorders cancer active or under treatment.
• Patients participating in other interventional research,
• Pregnant or breast-feeding women,
• Patients under guardianship.

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville Hopital Legouest

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pauline AMSTUTZ

  CHR Metz Thionville Hopital Legouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 15, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 4, 2027
• Study Completion (Estimated): July 19, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)