Telerehabilitation for Multiple Sclerosis (TRHBN)

September 18, 2025 updated by: University of Cadiz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain
        • Macarena University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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
Active Comparator: Control group
CG participants followed the exercise program and trained at home with images and videos as support.
Other: Exercise program
CG participants followed the exercise program and trained at home with images and videos as support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Ten weeks.
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.
Twenty weeks.
Strength endurance.
Time Frame: Baseline
Strength endurance was measured by the maximum number of unilateral knee flexion-extension repetitions performed in 30 seconds
Baseline
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 .
Baseline.
Strength endurance.
Time Frame: ten weeks
Strength endurance was measured by the maximum number of unilateral knee flexion-extension repetitions performed in 30 seconds
ten weeks
Strength endurance.
Time Frame: twenty weeks.
Strength endurance was measured by the maximum number of unilateral knee flexion-extension repetitions performed in 30 seconds
twenty weeks.
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.
ten weeks
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
Twenty weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Investigators

  • Principal Investigator: Lucía Ortega Carrión, Physiotherapy, Hospital Universitario macarena del servicio Andaluz de Salud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v.1 -11/12/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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