Telerehabilitation for Multiple Sclerosis

NCT06871072 | Completed

• 1 other identifier: v.1 -11/12/2023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

artificial intelligence; exercise; multiple sclerosis; physical therapy; strength; telerehabilitation

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (8)

• Maximal Strength.

  Ten weeks.

• Maximal Strength.

  Twenty weeks.

• Strength endurance.

  Baseline

• Endurance capacity.

  Baseline.

• Strength endurance.

  ten weeks

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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.

Other: Telerehabilitation

Control group

ACTIVE COMPARATOR

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

Other: Exercise program

Interventions

Telerehabilitation 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

Telerehabilitation

Exercise program OTHER

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

Control group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead

Study Sites (1)

Macarena University Hospital

Seville, Spain

Location

Related Publications (11)

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

  PMID: 18970977 BACKGROUND

• 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.

  PMID: 26888980 BACKGROUND

• 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.

  PMID: 36745446 BACKGROUND

• 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.

  PMID: 34606377 BACKGROUND

• 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.

  PMID: 29275977 BACKGROUND

• 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.

  PMID: 24871874 BACKGROUND

• 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.

  PMID: 34298940 BACKGROUND

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

  PMID: 17868019 BACKGROUND

• 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.

  PMID: 25872511 BACKGROUND

• 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.

  PMID: 27683916 BACKGROUND

• 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.

  PMID: 28915856 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Telerehabilitation; Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Exercise Therapy; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lucía Ortega Carrión, Physiotherapy

  Hospital Universitario macarena del servicio Andaluz de Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Enter the total number of arms participants might be assigned to over the course of the clinical study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A neurology will be diagnosed the Multiple sclerosis .

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: April 1, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-03

Locations

ES (1)