NCT06972355

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

Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Gait rehabilitation for stroke patients is a major issue in post-stroke functional recovery. The impact of vision on walking and balance is well documented, however, visuo-dependence (the dependence on vision for spatial orientation and balance control) is often neglected in current rehabilitation programs. Programs dealing with visuo-dependence mainly target pediatric, geriatric or chronic stroke populations, but their use and study remain limited in the literature. Moreover, these programs have never been studied in the context of the sub-acute phase of stroke. The issue of visuo-dependence is particularly relevant in this phase, as it occurs at a time when brain plasticity is still possible and appropriate rehabilitation strategies are needed. Aims The primary aim of this study is to evaluate the effects of treadmill walking training with vision suppression (eyes closed) on double-task walking speed. Secondary objectives are to study balance parameters, including lateral variance of the center of pressure (with eyes open and closed), area covered by the center of pressure (eyes open and closed), Romberg quotient and MCTSIB score. Gait parameters such as 10-meter test speed (10MWT), mean step duration, symmetry and cycle length variability will also be studied. Finally, proprioception parameters will be assessed using the JPS test. The primary hypothesis is that the absence of vision significantly improves the difference in walking speed between single-task and double-task walking. The secondary hypothesis is that this absence of vision would also improve proprioception parameters, gait quality and balance, by forcing increased activation of the other senses (proprioception, vestibular system), thus leading to somatosensory compensation. Methodology This randomized, controlled study will involve sub-acute stroke patients (\< 6 months), aged over 18, with deficits in walking, balance and proprioception. Participants will be randomly divided into two groups: an experimental group receiving gait training with eyes closed, and a control group practicing training with eyes open. Each participant will follow a rehabilitation program of 20 minutes of treadmill walking, three times a week, as part of physical therapy sessions lasting one hour a day, 5 times a week. Inclusion criteria included the ability to walk for 20 minutes on a treadmill with suspension and to walk 10 metres in the corridor, with or without technical aids. Exclusion criteria included severe associated pathologies and major cognitive impairment. Conclusion and clinical implications : This study is innovative in that it explores the effects of vision suppression on gait and balance rehabilitation, specifically in sub-acute stroke patients, a population often neglected in existing research. The results could offer new perspectives for post-stroke rehabilitation, focusing on sensory compensation via proprioception and other senses. This approach could ultimately improve patients' quality of life and autonomy, by reducing their dependence on vision and optimizing their motor rehabilitation.

Conditions

• Subacute Stroke

Interventions

Type	Name	Description
PROCEDURE	Hiding the eyes	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.

Timeline

• Start date: 2025-06-04
• Primary completion: 2027-06-04
• Completion: 2027-07-19
• First posted: 2025-05-15
• Last updated: 2025-10-01

Locations

1 site across 1 country: France