跳至主要内容
临床试验/NCT07178834
NCT07178834进行中(未招募)不适用

Impact of a Tele-rehabilitation Program on People With Multiple Sclerosis: A Multicenter, Randomized, Single-blind Study.

Multiple Sclerosis Center of Catalonia1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
75
试验地点
1
主要终点
Adverse events

研究概览

简要总结

The goal of this clinical trial is to assessing safety and the occurrence of adverse effects during tele-rehabilitation (TRHB) in people with multiple sclerosis with an EDSS score of 6.5 or lower. The main questions it aims to answer are:

  • Intervention using TRHB is considered safe and without adverse effects.
  • Intervention using TRHB has a high degree of self-adherence, an impact on physical activity levels and self-efficacy in exercise, and a positive effect on quality of life, mood, and perception of fatigue.

Researchers will compare the tele-rehabilitation with rehabilitation based solely on physical activity recommendations.

Participants will complete three weekly online rehabilitation sessions and must attend three follow-up visits.

详细描述

Multiple Sclerosis (MS) often entails a series of difficulties that cause some people to have high rates of absenteeism or even prevent them from benefiting from in-person rehabilitation treatments. The onset of the disease at a very young age, when the person is actively working or studying, the difficulty of balancing work and family life, mobility issues and lack of transportation, and geographical dispersion are some of the reasons why people with MS are not always able to access a neurorehabilitation center. Scientific evidence shows that functional and social barriers are the most common reasons why people do not adhere to rehabilitation. Home-based tele-rehabilitation (TRHB) is an alternative to rehabilitation in centers, allowing for remote supervision and the elimination of barriers. In addition, TRHB provides affected individuals and their families/caregivers with greater support in terms of care, mobility, and access to these services, and according to the World Health Organization (WHO), this type of assistance improves access to the healthcare system. There is a gap in research to identify the main adverse events related to tele-rehabilitation, and it is important to understand how adverse events, such as falls during physical therapy, are associated with the delivery of tele-rehabilitation.

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
Single (Outcomes Assessor)

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

  • •Patients diagnosed with multiple sclerosis confirmed using the 2017 McDonald criteria.
  • •Patients who have the technological means to conduct online sessions and the autonomy to do so.
  • •Patients with cognitive capacity that allows them to sign the informed consent form.
  • •Patients with an internet connection and a device compatible with the Rehub tele-rehabilitation platform (desktop computer, laptop, or tablet).
  • •EDSS level less than or equal to 6.5.

排除标准

  • •Participants who are currently undergoing RHB at a center.
  • •Participants who have undergone RHB during the two months prior to the start of the program.
  • •Patients with physical or mental comorbidities that may limit their participation in the rehabilitation program.

研究组 & 干预措施

Intervention group: tele-rehabilitation

Experimental

This group will do online rehabilitation three times a week. Every two weeks, an assessment will be made to determine whether to increase the intensity of the exercise

干预措施: Telerehab (Behavioral)

Control group: physical activity recommendations

No Intervention

This group will only have access to basic recommendations for physical activity.

结局指标

主要结局

Adverse events

时间窗: From enrollment to the end of treatment in week 8

Adverse events such as falls, pain, fatigue, and others that may occur.

次要结局

  • Multiple Sclerosis Quality of Life 54((T1) baseline, (T2) after the 8 week, (T3) at 16 week.)
  • 10 meters walking test((T1) baseline, (T2) after the 8 week, (T3) at 16 week.)
  • 6 minute walking test((T1) baseline, (T2) after the 8 week, (T3) at 16 week.)
  • Berg Balance Scale((T1) baseline, (T2) after the 8 week, (T3) at 16 week.)

研究者

发起方
Multiple Sclerosis Center of Catalonia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edwin Roger Meza Murillo

DR

Multiple Sclerosis Center of Catalonia

研究点 (1)

Loading locations...

相似试验