Impact of a Tele-rehabilitation Program on People With Multiple Sclerosis: A Multicenter, Randomized, Single-blind Study.
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: Multiple Sclerosis Center of Catalonia

 
 
 
Impact of a tele-rehabilitation program on 
people with multiple sclerosis: Multicenter, 
randomized, clinical study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 2. 15/01/2025 

1. Introduction 
Multiple sclerosis (MS) is an autoimmune disease of the central nervous system that is 
the leading non-traumatic cause of disability in young adults. It affects women two to 
three times more than men and presents with heterogeneous clinical manifestations, 
depending on the neurological areas involved, which complicates its management and 
requires individualized treatments and specialized care (1). Access to conventional 
rehabilitation is limited by multiple factors, such as the early onset of the disease during 
productive stages, the difficulty of balancing work and family life, limited mobility, 
lack of transportation, and the geographical dispersion of healthcare centers (2). These 
conditions, together with functional and social barriers, negatively affect therapeutic 
adherence. 
Given this situation, home-based telerehabilitation (HBR) has emerged as an effective 
alternative, allowing remote monitoring of patients and eliminating physical, logistical, 
and geographical obstacles, while also providing support to caregivers (3,4).  
According to the WHO, HRDT improves access to health services, allowing for a more 
personalized approach (5-8). It is not intended to replace face-to-face rehabilitation, but 
rather to complement it, being especially useful in patients with lesser disabilities, as it 
enhances treatment and promotes preventive activities through the use of advanced 
technologies (3,6,9). 
TRHB has proven effective in patients with acquired brain damage, improving 
functionality, mobility, and therapeutic acceptance (10,11). In MS, although more 
evidence is needed, preliminary studies indicate benefits in gait, balance, and cognitive 
functions such as memory and language (12).  
The present study aims to evaluate the impact of a TRHB program in people with MS. 
 
2. Objectives 
2.1 Main objective 
● To assess the safety and occurrence of adverse effects during the TRHB program. 
2.2 Secondary objectives 
• To assess the level of adherence to the TRHB program. 
• To determine the impact of a telerehabilitation program on the level of physical 
activity and self-efficacy regarding exercise in patients with multiple sclerosis. 
• Observe the impact on levels of anxiety, depression, and fatigue. 
• Observe the impact on health-related quality of life. 

• Evaluate the effectiveness of the TRHB intervention in terms of walking speed and 
balance. 
• Assess the degree of satisfaction of the participants. 
3. Methodology 
3.1 Study design 
This is a single-blind, randomized clinical study with a control group. 
• Intervention group: I conducted 24 tele-rehabilitation sessions (S24) three times a 
week using the platform for 8 weeks. 
• Control group: received a guide with general recommendations on physical activity. 
3.2 Inclusion criteria 
• Diagnosis of multiple sclerosis confirmed according to the 2017 McDonald criteria. 
• Availability of technological means to conduct the sessions online (computer, laptop, 
or tablet compatible with the Rehub-DyCare® platform). 
• Cognitive ability to understand and sign the informed consent form, and functional 
autonomy to perform the intervention. 
• EDSS score equal to or less than 6.5. 
3.3 Exclusion criteria 
• Participation in an active rehabilitation program at the time of starting the 
intervention. 
• Having undergone rehabilitation in the two months prior to the start of the study. 
• Presence of physical or psychological comorbidities that interfere with participation in 
the program. 
3.4 Selection of participants 
The invitation to participate was sent via email to people with multiple sclerosis (MS) 
registered in the Multiple Sclerosis Foundation (FEM) database who had authorized 
contact. Subsequently, individual telephone contact was made 
to provide further information and confirm interest in participating. In addition, some 
patients were invited from the outpatient clinics of the participating centers. 
Participant recruitment was carried out in strict chronological order of response to the 
survey and/or invitation 

from the outpatient clinics. Participants came from the FEM rehabilitation centers – 
CEMCAT (Barcelona), FEM Lleida, and FEM Reus. Those who agree to participate 
receive detailed information about the study verbally and in writing, and are asked to 
sign an informed consent form (ICF), in accordance with current regulations. 
Once the informed consent form has been signed, each patient is randomly assigned to 
the intervention or control group, without the evaluator knowing the assignment. 
The evaluations are carried out at three points in time: 
• T1: Initial evaluation, before starting the intervention. 
• T2: Intermediate evaluation, at the end of the intervention (8 weeks after T1). 
• T3: Final evaluation, 8 weeks after T2 (follow-up phase). 
The evaluations were performed by physical therapists specializing in MS, blinded to 
the assigned intervention group, at the following centers: CEMCAT (n=64), FEM 
Lleida (n=5), and FEM Reus (n=6). 
3.5 Randomization and masking 
After signing the informed consent form, participants were randomized using a block 
randomization system, with assignment by sealed envelopes. In this way, only they and 
the physical therapist in charge of the intervention knew which group they had been 
assigned to, 
thus ensuring the blinding of the evaluators. 
3.6 Intervention 
TRHB was carried out from each patient's home using the ReHub platform from 
DyCare (Spain). The program included 24 rehabilitation sessions, distributed over 3 
sessions per week for 8 weeks. Although it was recommended that they be carried out 
on Mondays, Wednesdays, and Fridays, 
participants were able to adjust the days according to their convenience. 
The objective of the sessions was to work on strength, mobility, proprioception, and 
balance, adapting the intensity in a personalized way. Follow-up was performed every 
two weeks, with additional supervision in the first week to correctly calibrate the initial 
load. In each session, perceived pain was assessed using the VAS scale and fatigue level 
using the Modified Borg scale, seeking to maintain the perceived effort between 6 and 7 
points. The platform includes more than 2,000 exercises, from which an initial exercise 
itinerary was constructed and subsequently adapted to each patient according to their 
level of resistance. Throughout the intervention, the load and variety of exercises were 
progressively adjusted. The progressive increase in load in the 

intervention group was achieved by increasing the number of sets and/or repetitions, 
decreasing the recovery time, or increasing the number of exercises in the session, 
depending on each individual's abilities. 
 
3.6.1 Intervention group (IG): 
• Received a guide on how to use the ReHub platform at T1. 
• Performed 24S of personalized TRHB for 8 weeks, with follow-up every two weeks 
by the therapist. 
• In T2, a guide with recommendations is provided to continue physical activity 
independently without support from the platform. 
• Follow-up after each session to adapt the workload and monitor possible incidents 
(between T1-T2). 
3.6.2 Control group (CG): 
• Received a guide with recommendations for physical activity in T1. 
• Does not participate in structured sessions; only follows their usual daily activities. 
• In T2, the importance of continuing with physical activity is reinforced. 
4. Statistical analysis 
For the description of demographic variables, measures of central tendency were used. 
Depending on the type of variable, the mean and standard deviation were used, as well 
as the median and range. 
To compare two means, the Kolmogorov-Smirnov test was used to check the normality 
of the different variables. Descriptive statistics of frequencies and percentages were 
calculated for the qualitative variables, and the mean and dispersion for the quantitative 
variables for each of the two groups. The sociodemographic and clinical variables and 
the level of PA were compared between the control and intervention groups using a χ2 
test for 
qualitative variables and a Student's t-test for quantitative variables that are normally 
distributed or a Mann-Whitney U test if they are not.