Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Dual-task walking speed assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 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.
排除标准
- •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.
研究组 & 干预措施
Hidden Eyes
Treadmill walking training with body weight reduced and eyes hidden
干预措施: Hiding the eyes (Procedure)
Open Eyes
Treadmill walking training with reduced body weight and open eyes.
结局指标
主要结局
Dual-task walking speed assessment
时间窗: 6 weeks after subacute stroke
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.
次要结局
- Cycle duration variability evaluation(3 to 6 monts after subacute stroke)
- 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)
- Single-task and double-task gait speed evaluation(3 to 6 monts after subacute stroke)
- Center of pressure position evaluation(up to 6 weeks after subacute stroke)
- Proprioception parameters evaluation using Romberg's quotient(up to 6 weeks after subacute stroke)
- Balance evaluation using CTSIB-M test(up to 6 weeks after subacute stroke)
- Proprioception using Join Position Sense of the knee test(up to 6 weeks after subacute stroke)