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Completed

NCT Number: NCT06871072

Telerehabilitation for Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Macarena University Hospital

Seville, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

exercise program

Other

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

Primary outcomes

  1. Maximal Strength

    Time frame: Baseline

    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.

Secondary outcomes

  1. Maximal Strength.

    Time frame: Ten weeks.

    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.

  2. Maximal Strength.

    Time frame: Twenty weeks.

    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.

  3. Strength endurance.

    Time frame: Baseline

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

  4. Endurance capacity.

    Time frame: Baseline.

    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 .

  5. Strength endurance.

    Time frame: ten weeks

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

  6. Strength endurance.

    Time frame: twenty weeks.

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

  7. Endurance capacity.

    Time frame: ten weeks

    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.

  8. Endurance capacity.

    Time frame: Twenty weeks

    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

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Official study title

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

Acronym: TRHBN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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