Telerehabilitation for Multiple Sclerosis

NCT ID: NCT06871072

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A neurology will be diagnosed the Multiple sclerosis .
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Enter the total number of arms participants might be assigned to over the course of the clinical study.

Study Groups

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Telerehabilitation

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.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type OTHER

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

Control group

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

Group Type ACTIVE_COMPARATOR

Exercise program

Intervention Type OTHER

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

Interventions

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Telerehabilitation

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

Intervention Type OTHER

Exercise program

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucía Ortega Carrión, Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario macarena del servicio Andaluz de Salud

Locations

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Macarena University Hospital

Seville, , Spain

Site Status

Countries

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Spain

References

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

Reference Type BACKGROUND
PMID: 18970977 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 36745446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34606377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29275977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24871874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34298940 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 17868019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25872511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27683916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28915856 (View on PubMed)

Other Identifiers

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v.1 -11/12/2023

Identifier Type: -

Identifier Source: org_study_id

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