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Recruiting NCT06972355

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

◆ AI Clinical Summary

This study compares two types of treadmill walking training for stroke patients in the early recovery phase (less than 6 months after stroke). One group will train while their vision is blocked or limited, while the other group will train with normal vision to see if blocking vision improves walking recovery.

Key Objective: The trial is testing whether treadmill walking with obscured vision leads to better walking ability and balance recovery compared to walking with normal vision in stroke patients.

Who to Consider: Stroke patients within 6 months of their stroke (either ischemic or hemorrhagic) who are in the early recovery phase and able to participate in treadmill training should consider enrolling.

Trial Parameters

Condition Subacute Stroke
Sponsor Centre Hospitalier Régional Metz-Thionville
Study Type INTERVENTIONAL
Phase N/A
Enrollment 36
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-04
Completion 2027-06-04
Interventions
Hiding the eyes

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.

Eligibility Criteria

Inclusion Criteria: 1. 18 years of age or older, 2. With a confirmed diagnosis of ischemic or hemorrhagic stroke in sub-acute phase (stroke less than 6 months old), 3. With NIHSS scores between 1 and 15 and MoCA scores between 18 and 30 4. With a physiotherapy prescription for post Stroke rehabilitation 5. 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, 6. Having expressed free, informed and written consent 7. Affiliated with a social security scheme. Exclusion Criteria: 1. Patients weighing over 200 kg (maximum weight permitted for use of the Lite Gait ®), 2. Patients with impaired vision: 1. Best corrected visual acuity below 5/10 on patient examination 2. Homonymous lateral hemianopia, quadranopia. 3. Inability to physically participate in intensive rehabilitation due to severe, unstabilized and comorbidities (heart, lung, kidney disease or diabetes)

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