Multiple Sclerosis
Conditions
Keywords
Telerehabilitation, Rehabilitatiton, Patient-Reported Outcome Measures
Brief summary
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.
Detailed 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.
Interventions
BEHAVIORALTelerehab
Adverse events are observed during online rehabilitation with computer vision technology in patients with MS.
Sponsors
Multiple Sclerosis Center of Catalonia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From enrollment to the end of treatment in week 8 | Adverse events such as falls, pain, fatigue, and others that may occur. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Quality of Life 54 | (T1) baseline, (T2) after the 8 week, (T3) at 16 week. | Quality of life scale (Min.0; Max.100). The higher the score, the better. |
| 10 meters walking test | (T1) baseline, (T2) after the 8 week, (T3) at 16 week. | The scale measures walking speed. There are no minimum or maximum measurements. The higher the reading, the better. |
| 6 minute walking test | (T1) baseline, (T2) after the 8 week, (T3) at 16 week. | The scale measures capacity for effort. There are no minimum or maximum measurements. The higher the score, the better. |
| Berg Balance Scale | (T1) baseline, (T2) after the 8 week, (T3) at 16 week. | The scale measures the level of balance. Minimum measurement 0; maximum 56. The higher the reading, the better. |
Countries
Spain
Outcome results
None listed