Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
研究概览
简要总结
The goal of this clinical investigation is to evaluate the effectiveness of home use of a lightweight robotic lower limb exoskeleton as a walking aid device on quality of life in patients with multiple sclerosis with gait disorders.
Participants will wear an exoskeleton (Keeogo) for 8 weeks at home during the experimental phase. This phase is compared to an 8-week control phase at home with advice on regular physical activity adapted to their abilities.
详细描述
It is a multicenter, controlled, randomized, cross-over, open-label clinical investigation.
Patients with multiple sclerosis with an Expanded Disability Status Scale (EDSS) between 5 and 6.5,living at home and using an assistive device for walking will be included.
After enrollment, patients will be randomised in one of the 2 study-arm.
- Arm A: experimental phase / Wash-Out (WO) (8 weeks) / control phase
- Arm B: control phase / WO (8 weeks) / experimental phase
During the experimental phase, patients will receive a Keeogo specific training for five days. The purpose of this training programme is to ensure familiarity and acceptance of the device. Then, the patients will take Keeogo home and will have to use the device as much as possible indoors and outdoors for seven weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patient with multiple sclerosis according to the revised Mac Donald diagnostic criteria (2017) in the relapsing-remitting form more than 6 months from a relapsing or progressive period.
- •An Expanded Disability Status Scale (EDSS) between 5 and 6.5 on the EDSS scale (Kurtzke 1983)
- •Living at home
- •Using a walking aid
- •18 years old or older
- •Have freely consented to participate in this study
- •To be more than 1m52 tall
- •Hip Manual Muscle Testing (MMT) score ≥ 3+ (flexors and expanders)
- •Knee Manual Muscle Testing (MMT) score ≥ 2 (flexors and expanders)
- •Berg scale (BBS) score > 20
- •Patient affiliated with a social security plan or beneficiary of such a plan.
- •Non-Inclusion Criteria:
- •Impaired comprehension preventing completion of the protocol
- •Inability to walk without assistance for 10 minutes
- •Have a rehabilitation stay scheduled during the follow-up period of the clinical investigation
- •Diagnosed psychiatric conditions that may have an impact on the experience of withdrawal of technical assistance at the end of the protocol
- •Severe cognitive impairment (MMSE<24)
- •Person deprived of liberty by a judicial or administrative decision
- •A person under psychiatric care or admitted to a health or social institution for purposes other than research.
- •Spasticity >3 on the Held and Tardieu scale affecting the hamstring, quadriceps, adductor or sural triceps muscles
- •Complete paralysis of the lower limbs
- •Severe osteoporosis
- •Hip and/or knee replacements that would sufficiently limit range of motion for walking and sitting or squatting
- •Severe vascular disorders of the lower limbs
- •Existing wounds or skin lesions where the device is worn
- •Pregnant woman or postpartum woman who has not completed lumbopelvic recovery
- •Orthopedic disorders of the lower limb that may prevent satisfactory adjustment of Keeogo
- •Uncontrolled epilepsy or tremors
- •Uncontrolled autonomic dysreflexia
- •Severe balance disorders, neurological disorders (any condition that prevents the safe control of balance and/or movement of the limbs at all times while wearing the Keeogo System)
- •Conditions that prevent safe moderate-intensity exercise
排除标准
- 未提供
结局指标
主要结局
Evolution of the quality of life assessed with the "Functional Assessment Of Multiple Sclerosis" questionnaire (change between two time points)
时间窗: Screening visit and visit after experimental phase (Week 8 for Arm A; Week 24 for Arm B)
The Functional Assessment Of Multiple Sclerosis (FAMS) is a self-administered health questionnaire related to quality of life for patients with multiple sclerosis
次要结局
- Spasticity of the quadriceps, hamstrings and abductors muscles(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (3)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance with the Keeogo exoskeleton (4)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance with the Keeogo exoskeleton (3)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Satisfaction with this new home technical aid(After experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Projection in use(After experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance without exoskeleton (6)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance with the Keeogo exoskeleton (5)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance with the Keeogo exoskeleton (6)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Sense of self-efficacy(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (1)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (4)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance with the Keeogo exoskeleton (1)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- Walking and balancing performance with the Keeogo exoskeleton (2)(after experimental phase (Week 8 for Arm A; Week 24 for Arm B))
- The average daily distance travelled(At study visits (Week 8, Week 24, Month 9))
- Fatigue(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Anxiety and depression(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (2)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))
- Walking and balancing performance without exoskeleton (5)(At all study visits (Screening, Week 8, Week 16, Week 24, Month 9))