AzTrials
AzTrials

Multiple SclerosisTRHBNNCT06871072

Telerehabilitation for Multiple Sclerosis

A study testing Telerehabilitation and Exercise program in people with Multiple Sclerosis, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple sclerosis (MS) is a neurodegenerative disease affecting the central nervous system and is a leading cause of disability in young adults. It often produces strength deficits. Exercise has been shown to improve strength, mobility, and quality of life while reducing fatigue. Read more about this study

Who is it for?
Ages 35 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Telerehabilitation and Exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteSpain
Study dates
1 Apr 2025to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 35 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Diagnosis of multiple sclerosis according to the McDonald criteria 2017:
  • Age between 35 and 60 years.
  • Score on the Expanded Disability Status Scale in Multiple Sclerosis by Kurtzke (EDSS) between 2 and 6 points.
  • Patients who do not require assistive devices for home mobility.
  • Patients with no changes in disease-modifying treatment in the last 3 months.
  • Patients who have understood, completed, and signed the informed consent and the study information sheet.

Who cannot join

  • Patients who have been regularly performing strength exercises for more than 3 months prior.
  • Moderate/severe cognitive impairment that may interfere with the understanding and/or execution of the study.
  • History of alcohol and/or drug abuse.
  • Presence of a relapse and/or treatment with corticosteroids within the four weeks prior to the start of the study.
  • Patients with severe comorbidities other than MS that may pose a risk for following the exercise guidelines or for their participation in the study for other reasons.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Macarena University Hospital

    Seville

Other trials in Spain

About this study

Official title: Telerehabilitation for Multiple Sclerosis: Artificial Intelligence vs. Conventional Approaches in Strength Training. A Sin-gle-Blinded Randomized Clinical Trial

Multiple sclerosis (MS) is a neurodegenerative disease affecting the central nervous system and is a leading cause of disability in young adults. It often produces strength deficits. Exercise has been shown to improve strength, mobility, and quality of life while reducing fatigue. Telerehabilitation offers a convenient, accessible alternative for MS patients. This study explores the use of an AI-powered application for prescribing and monitoring strength exercises, ensuring continuous feedback and adherence. Methods: Randomized clinical trial. Intervention of 3 weekly strength training ses-sions for 20 weeks, patients in the experimental group used the AI application, while patients in the control group followed the conventional method, paper-based exercises with access to videos.

Being tested
Telerehabilitation, Exercise program
Keywords
artificial intelligence, exercise, multiple sclerosis, physical therapy, strength, telerehabilitation
Medical subject headings
Multiple Sclerosis, Motor Activity

What participants receive

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

  • TelerehabilitationOther

    EG performed using an artificial intelli-gence (AI) application called RehBody, which detects body segments, assists in cor-recting the technique and monitoring the exercise, number of sets and repetitions done, and the adherence percentage

  • Exercise programOther

    CG participants followed the exercise program and trained at home with images and videos as support.

Study groups in NCT06871072
Study groupRoleWhat they receive
TelerehabilitationExperimentalEG performed using an artificial intelli-gence (AI) application called RehBody, which detects body segments, assists in cor-recting the technique and monitoring the exercise, number of sets and repetitions done, and the adherence percentage.
Receives: Other: Telerehabilitation
Control groupActive comparatorCG participants followed the exercise program and trained at home with images and videos as support.
Receives: Other: Exercise program

What is being measured

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

  1. Maximal Strength

    Maxi-mal Strength was assessed using an 8-repetition maximum test , in which par-ticipants perform 8 repetitions of squat and bench press as the resistance is gradually increased until a load is determined where only eight repetitions can be performed. The load increment was determined based on the result from the Modified Borg Scale at the end of the exercise, if the Borg rating was greater than 7, the test was completed.

    Measured: Baseline

Secondary outcomes (8)
  1. Maximal Strength.

    Maxi-mal Strength was assessed using an 8-repetition maximum test, in which par-ticipants perform 8 repetitions of squat and bench press as the resistance is gradually increased until a load is determined where only eight repetitions can be performed. The load increment was determined based on the result from the Modified Borg Scale at the end of the exercise, if the Borg rating was greater than 7, the test was completed.

    Measured: Ten weeks.

  2. Maximal Strength.

    Maxi-mal Strength was assessed using an 8-repetition maximum test, in which par-ticipants perform 8 repetitions of squat and bench press as the resistance is gradually increased until a load is determined where only eight repetitions can be performed. The load increment was determined based on the result from the Modified Borg Scale at the end of the exercise, if the Borg rating was greater than 7, the test was completed.

    Measured: Twenty weeks.

  3. Strength endurance.

    Strength endurance was measured by the maximum number of unilateral knee flexion-extension repetitions performed in 30 seconds

    Measured: Baseline

  4. Endurance capacity.

    Endurance capacity as secondary variable was measured by 6-minutes walking test , where participants covering the maximum distance on a flat surface in 6 minutes. Fatigue was quantified by Modified Fatigue Impact Scale .

    Measured: Baseline.

  5. Strength endurance.

    Strength endurance was measured by the maximum number of unilateral knee flexion-extension repetitions performed in 30 seconds

    Measured: ten weeks

  6. Strength endurance.

    Strength endurance was measured by the maximum number of unilateral knee flexion-extension repetitions performed in 30 seconds

    Measured: twenty weeks.

  7. Endurance capacity.

    Endurance capacity as secondary variable was measured by 6-minutes walking test , where participants covering the maximum distance on a flat surface in 6 minutes. Fatigue was quantified by Modified Fatigue Impact Scale.

    Measured: ten weeks

  8. Endurance capacity.

    Endurance capacity as secondary variable was measured by 6-minutes walking test, where participants covering the maximum distance on a flat surface in 6 minutes. Fatigue was quantified by Modified Fatigue Impact Scale

    Measured: Twenty weeks

Timeline

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

  1. First posted11 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion15 Aug 2025
  4. Study completion31 Aug 2025

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
Model description
A neurology will be diagnosed the Multiple sclerosis .
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06871072
Sponsor's protocol ID
v.1 -11/12/2023
Acronym
TRHBN
Status last verified
Mar 2025
First submitted
27 Feb 2025
Last updated
19 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

    PubMed 18970977
  • Dilokthornsakul P, Valuck RJ, Nair KV, Corboy JR, Allen RR, Campbell JD. Multiple sclerosis prevalence in the United States commercially insured population. Neurology. 2016 Mar 15;86(11):1014-21. doi: 10.1212/WNL.0000000000002469. Epub 2016 Feb 17.

    PubMed 26888980
  • Meier S, Willemse EAJ, Schaedelin S, Oechtering J, Lorscheider J, Melie-Garcia L, Cagol A, Barakovic M, Galbusera R, Subramaniam S, Barro C, Abdelhak A, Thebault S, Achtnichts L, Lalive P, Muller S, Pot C, Salmen A, Disanto G, Zecca C, D'Souza M, Orleth A, Khalil M, Buchmann A, Du Pasquier R, Yaldizli O, Derfuss T, Berger K, Hermesdorf M, Wiendl H, Piehl F, Battaglini M, Fischer U, Kappos L, Gobbi C, Granziera C, Bridel C, Leppert D, Maleska Maceski A, Benkert P, Kuhle J. Serum Glial Fibrillary Acidic Protein Compared With Neurofilament Light Chain as a Biomarker for Disease Progression in Multiple Sclerosis. JAMA Neurol. 2023 Mar 1;80(3):287-297. doi: 10.1001/jamaneurol.2022.5250.

    PubMed 36745446
  • Rodriguez Murua S, Farez MF, Quintana FJ. The Immune Response in Multiple Sclerosis. Annu Rev Pathol. 2022 Jan 24;17:121-139. doi: 10.1146/annurev-pathol-052920-040318. Epub 2021 Oct 4.

    PubMed 34606377
  • Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.

    PubMed 29275977
  • Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

    PubMed 24871874
  • Podbielska M, O'Keeffe J, Pokryszko-Dragan A. New Insights into Multiple Sclerosis Mechanisms: Lipids on the Track to Control Inflammation and Neurodegeneration. Int J Mol Sci. 2021 Jul 7;22(14):7319. doi: 10.3390/ijms22147319.

    PubMed 34298940
  • Boissy AR, Cohen JA. Multiple sclerosis symptom management. Expert Rev Neurother. 2007 Sep;7(9):1213-22. doi: 10.1586/14737175.7.9.1213.

    PubMed 17868019
  • Galea I, Ward-Abel N, Heesen C. Relapse in multiple sclerosis. BMJ. 2015 Apr 14;350:h1765. doi: 10.1136/bmj.h1765. No abstract available.

    PubMed 25872511
  • Lizak N, Lugaresi A, Alroughani R, Lechner-Scott J, Slee M, Havrdova E, Horakova D, Trojano M, Izquierdo G, Duquette P, Girard M, Prat A, Grammond P, Hupperts R, Grand'Maison F, Sola P, Pucci E, Bergamaschi R, Oreja-Guevara C, Van Pesch V, Ramo C, Spitaleri D, Iuliano G, Boz C, Granella F, Olascoaga J, Verheul F, Rozsa C, Cristiano E, Flechter S, Hodgkinson S, Amato MP, Deri N, Jokubaitis V, Spelman T, Butzkueven H, Kalincik T; MSBase Study Group. Highly active immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Mar;88(3):196-203. doi: 10.1136/jnnp-2016-313976. Epub 2016 Sep 28.

    PubMed 27683916
  • Halabchi F, Alizadeh Z, Sahraian MA, Abolhasani M. Exercise prescription for patients with multiple sclerosis; potential benefits and practical recommendations. BMC Neurol. 2017 Sep 16;17(1):185. doi: 10.1186/s12883-017-0960-9.

    PubMed 28915856

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation and Exercise program in people with Multiple Sclerosis, run by University of Cadiz 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 19 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximal Strength (time frame: Baseline). 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 NCT06871072, which also lists 11 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 19 Sep 2025.

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