Clinical trial NCT06871072: Telerehabilitation for Multiple Sclerosis
Official title: Telerehabilitation for Multiple Sclerosis: Artificial Intelligence vs. Conventional Approaches in Strength Training. A Sin-gle-Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: artificial intelligence
exercise
multiple sclerosis
physical therapy
strength
telerehabilitation
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 58
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A neurology will be diagnosed the Multiple sclerosis .
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximal Strength
timeFrame: Baseline
Secondary outcomes:
measure: Maximal Strength.
timeFrame: Ten weeks.
measure: Maximal Strength.
timeFrame: Twenty weeks.
measure: Strength endurance.
timeFrame: Baseline
measure: Endurance capacity.
timeFrame: Baseline.
measure: Strength endurance.
timeFrame: ten weeks
measure: Strength endurance.
timeFrame: twenty weeks.
measure: Endurance capacity.
timeFrame: ten weeks
measure: Endurance capacity.
timeFrame: Twenty weeks
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Macarena University Hospital
Study officials:
affiliation: Hospital Universitario macarena del servicio Andaluz de Salud
name: Lucía Ortega Carrión, Physiotherapy
role: PRINCIPAL_INVESTIGATOR
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