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临床试验/NCT05563402
NCT05563402
已完成
不适用

"Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis"

Multiple Sclerosis Center of Catalonia2 个研究点 分布在 1 个国家目标入组 15 人2022年9月20日

概览

阶段
不适用
干预措施
Atalante
疾病 / 适应症
Multiple Sclerosis
发起方
Multiple Sclerosis Center of Catalonia
入组人数
15
试验地点
2
主要终点
To describe usability of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS) and explore patient characteristics related to this feature.
状态
已完成
最后更新
9天前

概览

简要总结

Multiple sclerosis (MS) is the most prevalent chronic inflammatory disease of the central nervous system (CNS), affecting more than 2 million people worldwide,1 it is a degenerative disease that selectively affects the central nervous system and represents the main cause of non-traumatic disability in young adults.

Gait and balance disturbances in MS are common even in the early stages of the disease. Half of the patients report some alteration in the quality of walking within the first month after diagnosis, reaching 90% after 10 years of evolution. 4 5 In addition, it is the symptom to which patients give the most importance 6 and the one that most conditions their activity and participation. 7 The causes of gait disturbance are multifactorial and are influenced by different aspects such as muscle strength, balance, coordination, proprioception, vision, spasticity, fatigue and even cognitive aspects4.

There are multiple interventions, including aerobic, resistance training, yoga, and combined exercise, that have shown significant improvements in walking endurance, regardless of outcome measures (six-minute walking test (6MWT), two-minute walking test 2MWT). 8

In recent years, evidence has been growing around rehabilitation with robotic equipment in people with multiple sclerosis (PwMS), in their study Ye et al. concluded that robotic locomotor training has limited impact on motor functions in multiple sclerosis, but improves fatigue and spasticity, is safe and well-tolerated for PwMS, and less demanding for physical therapists.10 Bowman et al. concluded that robot-assisted gait therapy (RAGT) improves balance and gait outcomes in a clinically significant way in PwMS, RAGT appears more effective compared to non-specific rehabilitation, while showing similar effects compared to non-specific rehabilitation. specific balance and gait training in studies with level 2 evidence. RAGT has several advantages in terms of patient motor assistance, training intensity, safety and the possibility of combining other therapeutic approaches and should be promoted for PwMS with disability in a multimodal rehabilitation setting as an opportunity to maximize recovery.11 In this setting, more larger-scale and better-designed studies with longer training duration and more studies evaluating satisfaction, usability, and effectiveness are needed. of RAGT.

详细描述

Therefore, the investigators propose an open, non-randomized, pseudo-experimental study. This study protocol includes 12 one-hour RAGT training sessions for 4 weeks, three times a week, under the supervision of a qualified rehabilitation team. Informed consent will be obtained from patients before inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki. With the aim of describing Usability as the main objective, and Safety as a secondary objective and functional changes at the level of balance, walking speed and quality of life.

注册库
clinicaltrials.gov
开始日期
2022年9月20日
结束日期
2023年3月30日
最后更新
9天前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Multiple Sclerosis Center of Catalonia
责任方
Principal Investigator
主要研究者

Edwin Roger Meza Murillo

Principal Investigator

Multiple Sclerosis Center of Catalonia

入排标准

入选标准

  • Male or female, between 18 and 65 years of age
  • Confirmed diagnosis of MS
  • Expanded Disability Status Scale (EDSS) de Kurtzke from 6.0 to 7.0
  • Able to verticalize on a daily basis
  • Stable course of disease-modifying therapy over the past 6 months
  • Clinical comorbidity asymptomatic (i.e., no underlying cardiovascular disease)
  • Height: between approximately 1.60 and 1.90 m.
  • Willingness to visit the Multiple Sclerosis Center of Catalonia (CEMCAT) for testing and training.
  • Gait disorder conditioned by paresis or hemiparesis associated with ataxia or sensory problems
  • Patient having given written consent

排除标准

  • Pregnancy
  • Starting or switching from fampridine (Fampyra®) in the last 4 weeks
  • Height and weight outside the secure standard of safe use, described in the safety guides
  • Contraindications to training with Atalante (eg, bone instability, history of osteoporosis or osteoporotic fractures)
  • Subjects under Corticosteroids treatment or relapse
  • Changes in disease-modifying and symptomatic therapy for MS during the study period
  • Subjects with psychiatric or cognitive comorbidities that may interfere with the trial
  • Whose joint centers cannot be aligned Atalante's
  • Ranges of motion below:
  • Knee: 5° extension, 110° flexion

研究组 & 干预措施

Treatment arm

Therefore, the investigators propose an, open, non-randomized study. This study protocol includes 12 one-hour RAGT training sessions for 4 weeks, three times a week, under the supervision of a qualified rehabilitation team. Informed consent will be obtained from patients before inclusion in the study, which will be carried out in accordance with the Declaration of Helsinki. With the aim of describing Usability as the main objective, and Safety as a secondary objective and functional changes at the level of balance, walking speed and quality of life.

干预措施: Atalante

结局指标

主要结局

To describe usability of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS) and explore patient characteristics related to this feature.

时间窗: 4 months

Defining usability as a quality attribute that evaluates the ease of use of user interfaces, evaluating the perspective of patients by the Satisfaction Quebec user Evaluation of Satisfaction with assistive technology (QUEST) score and a questionnaire specific to the use of Atalante device. Defining high Usability as: Obtaining a positive score greater than or equal to 70% of the total possible score on the Satisfaction Quebec user Evaluation of Satisfaction with assistive technology (QUEST) score.

次要结局

  • To describe the effect at the self-perception and psychological level of RAGT using the Atalante self-balancing exoskeleton to improve quality of life.(4 months)
  • To describe safety of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS), measured by the occurrence of pressure ulcers(4 months)
  • To describe safety and occurrence of adverse effect of Robotic-Assisted Gait therapy (RAGT) using the Atalante self-balance exoskeleton for persons with multiple sclerosis (PwMS).(4 months)
  • To describe the effect at the functional level of RAGT using the Atalante self-balance. Physiological Changes at Bowel Dysfunction(4 months)
  • To describe the effect at the functional level of RAGT using the Atalante self-balance exoskeleton for improving Balance outcome.(4 months)
  • To describe the effect at the self-perception and psychological level of RAGT using the Atalante self-balancing exoskeleton to improve quality of life and depression.(4 months)
  • To describe the effect at the functional level of RAGT using the Atalante self-balance exoskeleton for improving Walking speed, quality of life, depression.(4 months)

研究点 (2)

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