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Multiple SclerosisTelerehabNCT07178834

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

A study testing Telerehab in people with Multiple Sclerosis, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Telerehab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
10 Feb 2025to 30 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Multiple Sclerosis Center of Catalonia

    Barcelona, 08035

Other trials in Spain

About this study

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

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.
Read more

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.

Read the 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.

Being tested
Telerehab
Keywords
Telerehabilitation, Rehabilitatiton, Patient-Reported Outcome Measures
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabBehavioural

    Also called Telerehabilitation, Intervention group

    Adverse events are observed during online rehabilitation with computer vision technology in patients with MS.

Study groups in NCT07178834
Study groupRoleWhat they receive
Intervention group: tele-rehabilitationExperimentalThis 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
Receives: Behavioral: Telerehab
Control group: physical activity recommendationsNo interventionThis group will only have access to basic recommendations for physical activity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

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

    Measured: From enrollment to the end of treatment in week 8

Secondary outcomes (4)

  1. Multiple Sclerosis Quality of Life 54

    Quality of life scale (Min.0; Max.100). The higher the score, the better.

    Measured: (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

  2. 10 meters walking test

    The scale measures walking speed. There are no minimum or maximum measurements. The higher the reading, the better.

    Measured: (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

  3. 6 minute walking test

    The scale measures capacity for effort. There are no minimum or maximum measurements. The higher the score, the better.

    Measured: (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

  4. Berg Balance Scale

    The scale measures the level of balance. Minimum measurement 0; maximum 56. The higher the reading, the better.

    Measured: (T1) baseline, (T2) after the 8 week, (T3) at 16 week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start10 Feb 2025
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178834
Sponsor's protocol ID
PR(AG)498/2024
Acronym
Telerehab
Status last verified
Sep 2025
First submitted
4 Jul 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yau T, McIntyre M, Chan J, Bhogal D, Andreoli A, Bayley M, Leochico CFD, Kua A, Guo M, Munce S. Adverse events associated with the delivery of telerehabilitation: A scoping review protocol. PLoS One. 2024 Feb 21;19(2):e0297908. doi: 10.1371/journal.pone.0297908. eCollection 2024.

    PubMed 38381732

  • Doherty F, Lynch P, Powell P, Monaghan K. Feasibility and effectiveness of telerehabilitation on mobility and balance function in multiple sclerosis: A systematic review and meta-analysis. J Neurol Sci. 2024 Nov 15;466:123214. doi: 10.1016/j.jns.2024.123214. Epub 2024 Sep 4.

    PubMed 39270413

  • Xiang XM, Bernard J. Telehealth in Multiple Sclerosis Clinical Care and Research. Curr Neurol Neurosci Rep. 2021 Feb 28;21(4):14. doi: 10.1007/s11910-021-01103-4.

    PubMed 33646409

  • Harkey LC, Jung SM, Newton ER, Patterson A. Satisfacció del pacient amb la telesalud en entorns rurals: una revisió sistemàtica. Revista Internacional de Telerehabilitació. 2020;12(2):53-64. doi: 10.5195/ijt.2020.6303

  • Fjeldstad-Pardo C, Thiessen A, Pardo G. Telerehabilitation in Multiple Sclerosis: Results of a Randomized Feasibility and Efficacy Pilot Study. Int J Telerehabil. 2018 Dec 11;10(2):55-64. doi: 10.5195/ijt.2018.6256. eCollection 2018 Fall.

    PubMed 30588276

Questions about this trial

What is this clinical trial studying?

A study testing Telerehab in people with Multiple Sclerosis, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: From enrollment to the end of treatment in week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07178834, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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