Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.
研究概览
简要总结
Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients.
This is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.
详细描述
Following an initial study carried out by the team (cf citation), physiotherapy appeared to be the most useful therapy for coping with spasticity, particularly when practised at least 3 times a week. The hypothesis is that this feeling experienced by patients is accurate, and that more frequent physiotherapy (3 additional sessions/week) significantly improves patients' walking speed, with a functional objective.
The main aim of the WALK-UP study is to evaluate the efficacy of a 6-week intensive physical rehabilitation program on walking speed in patients with SPG4 / SPAST-HSP. This is the most frequent genotype in Hereditary Spastic Paraparesis. All patients included in the study will receive at least one physiotherapy session per week in a liberal practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene,
- •Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses),
- •At least 1 physiotherapy session per week already in place.
- •Understanding of the protocol
- •Possibility of connecting to the Internet from home to access video material provided as part of the protocol.
排除标准
- •Botulinum toxin injection within 2 months of protocol inclusion
- •Discontinuation of private physiotherapy,
- •Refusal to participate in the protocol,
- •Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial
- •Pregnant women
- •Not affiliated to a social security scheme or beneficiary of such a scheme
- •Patient under guardianship or trusteeship
结局指标
主要结局
to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.
时间窗: 6 weeks
6-minute walk test carried out in the presence of a clinician trained in this test. The patient walks for 6 minutes on a circuit of known distance, identical for each patient. The clinician times the walking time and measures the distance covered during 6 minutes. This test is performed at inclusion and again at 6 weeks
次要结局
- compare the clinical evolution of spasticity(18 weeks)
- compare the before-after variation in walking speed over a 10-meters test(18 weeks)
- compare the before-after variation in the daily number of steps(18 weeks)
- compare the fatigue(18 weeks)
- compare the before-after variation in distance covered in 6 minutes(18 weeks)
- compare the evolution of cognitive disorders(18 weeks)
- compare the anorectal disorders(18 weeks)
- compare the patients' mood evolution(18 weeks)
- compare the quality of life(18 weeks)
- compare the lower-limb joint amplitudes(18 weeks)
- compare the before-after variation in heart rate(18 weeks)
- compare the frequency and intensity of vesico-sphincter disorders(18 weeks)