Impact of a Tele-rehabilitation Program on People With Multiple Sclerosis (Telerehab)

Multiple Sclerosis Center of Catalonia

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Behavioral: Telerehab

Study type: Interventional

Funder types: Other

Identifiers

NCT07178834

PR(AG)498/2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Intervention group: tele-rehabilitation

Experimental group

Description:

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

Treatment:

Behavioral: Telerehab

Control group: physical activity recommendations

No Intervention group

Description:

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