NCT04772027招募中不适用
Characterization and Identification of Motor Parameters Using Instrumental Assessment in Patients With Limb Girdle Muscular Dystrophy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline on peak hip flexion
研究概览
简要总结
The primary objective of the study is to perform 2-year follow up with motor parameters evolution using instrumental assessments in patients with limb girdle muscular dystrophie, and to identify which motor parameters are sensitive to change.
The secondary objectives of the study are:
- to describe the changes of the parameters obtained from instrumental evaluations in comparison with the changes obtained from clinical assessments.
- to characterize the muscular impairments, the biomechanical gait disorders, the standing postural control disorders, the biomechanical upper limb disorders in spatial exploration, the limitation of upper limb capacities, the fatigue, the endurance, the patients' participation to their activities and their quality of life, in comparison with a healthy paired population.
- to highlight the relationships between muscular assessment parameters, biomechanical gait parameters, standing posture control and upper limb spatial exploration.
- to highlight the relationships between data from instrumental assessments and data from clinical assessments.
- to highlight the relationships between instrumental assessments data and clinical assessments data on one side, and features of patients (age, sex, duration since diagnosis, type of LGMD, rehabilitation in follow-up, sportive practices...) on the other side.
详细描述
This is a monocentric study in which 2 sub-groups of people will be enrolled: LGMD patients and healthy volunteers. Each enrolled LGMD patient will have 5 visits during 2 years, one baseline visit and four half-yearly visits. Each enrolled healthy volunteer will have one planned visit only. The duration of enrollments will last 20 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For limb girdle muscular dystrophie group:
- •Patients diagnosed limb girdle muscular dystrophie;
- •Aged between 18 and 70 years;
- •Covered by the French social security scheme;
- •Patient able to maintain upright position alone;
- •Able to walk at least 10 meters and 6 minutes consecutively without help.
- •For Volunteer group:
- •Adult (18 to 70 years) without neuromuscular or squeletic disorder.
排除标准
- •Without associated neuromuscular disorders such as respiratory or muscular-squeletic diseases, apart from the consequences of dystrophy;
- •Contraindication to the tests;
- •Noncontrol cardiac rhythm disorders;
- •Lying down position intolerance due to severe respiratory troubles;
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Change from baseline on peak hip flexion
时间窗: Assessed at 6 months, 12 months, 18 months and 24 months
Hip flexion peak during gait will be evaluated with tridimensional gait analysis with an optoelectronic system ((Optitrack system, Natural Point Inc. Corvallis, OR, USA)
Change from baseline on maximal strength
时间窗: Assessed at 6 months, 12 months, 18 months and 24 months
Maximal strength and muscular activation of knee extensors will be evaluated by isometric test with an isokinetic dynamometer (Biodex Medical Systems Inc., Shirley, New York, USA).
Change from baseline on speed of center of pression during standing postural control
时间窗: Assessed at 6 months, 12 months, 18 months and 24 months
Speed of center of pression will be measured by force platforms (AMTI, Advanced Mechanical Technology).
Change from baseline on elbow peak extension during upper limb spatial exploration
时间窗: Assessed at 6 months, 12 months, 18 months and 24 months
Elbow peak extension will be measured biomechanically with an optoelectronic system during upper limb spatial exploration (Optitrack system, Natural Point Inc. Corvallis, OR, USA)
次要结局
- Change from baseline on number of physiotherapy sessions per week(at baseline, 6 months, 12 months, 18 months and 24 months)
- Change from baseline on muscular parameters(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on step length(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on standing postural control parameters: Romberg quotient(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on step width(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on drinking task with left and right upper limb: velocity and movement time(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on drinking task with left and right upper limb: trunk displacement(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on gait speed(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on % swing phase of gait cycle(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on % support phase of gait cycle(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on kinetic gait parameters(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on locomotor(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on patient occupations(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on number of fall risks(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on Individualized Neuromuscular Quality of Life Questionnaire (INQoL)(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on % single support phase of gait cycle(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on standing postural control parameters: COP displacements(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on standing postural orientation parameters(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on drinking task with left and right upper limb: movement strategy(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on drinking task with left and right upper limb: angular joint(Assessed at 6 months, 12 months, 18 months and 24 months)
- Joint kinematic parameters: change from baseline on cadence(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on standing postural control parameters: elliptic surface(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on standing postural control parameters: Amplitude of COP(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on drinking task with left and right upper limb: smoothness and coordination movement(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on number of sports practice per week(at baseline, 6 months, 12 months, 18 months and 24 months)
- Change from baseline on standing postural orientation parameters: limb loading ratio(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on 6 minutes walking test distance(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on Brooke Upper Extremity Scale score(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on upper limb capacities(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on Fatigue Severity Scale (FSS) score(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on the Berg Balance Scale score(Assessed at 6 months, 12 months, 18 months and 24 months)
- Change from baseline on MRC (Medical Research Council) score on flexors and extensors of lower and upper limb(Assessed at 6 months, 12 months, 18 months and 24 months)
研究者
研究点 (1)
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