Clinical trial NCT06972355: Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke
Official title: Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subacute Stroke
Keywords: Stroke
Gait
Treadmill
Double task
Proprioception
Postural balance
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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), severe psychiatric disorders cancer active or under treatment.
4. Patients participating in other interventional research,
5. Pregnant or breast-feeding women,
6. Patients under guardianship.

Primary outcomes:
measure: Dual-task walking speed assessment
timeFrame: 6 weeks after subacute stroke
Secondary outcomes:
measure: Gait Speed assessment
timeFrame: 3 to 6 monts after subacute stroke
measure: Average step duration evaluation
timeFrame: 3 to 6 monts after subacute stroke
measure: Gait symmetry evaluation
timeFrame: 3 to 6 monts after subacute stroke
measure: Cycle duration variability evaluation
timeFrame: 3 to 6 monts after subacute stroke
measure: Single-task and double-task gait speed evaluation
timeFrame: 3 to 6 monts after subacute stroke
measure: Center of pressure position evaluation
timeFrame: up to 6 weeks after subacute stroke
measure: Proprioception parameters evaluation using Romberg's quotient
timeFrame: up to 6 weeks after subacute stroke
measure: Balance evaluation using CTSIB-M test
timeFrame: up to 6 weeks after subacute stroke
measure: Proprioception using Join Position Sense of the knee test
timeFrame: up to 6 weeks after subacute stroke
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville Hopital Legouest
Study officials:
affiliation: CHR Metz Thionville Hopital Legouest
name: Pauline AMSTUTZ
role: PRINCIPAL_INVESTIGATOR
References: