Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT07178834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of a Tele-rehabilitation Program on People With Multiple Sclerosis
Sponsor:
Multiple Sclerosis Center of Catalonia
Organization:
Study Overview
Official Title:
Impact of a Tele-rehabilitation Program on People With Multiple Sclerosis: A Multicenter, Randomized, Single-blind Study.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Telerehab
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: