Telerehabilitation for Multiple Sclerosis: Artificial Intelligence vs. Conventional Approaches in Strength Training. A Sin-gle-Blinded Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Cadiz
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Maximal Strength
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Enter the total number of arms participants might be assigned to over the course of the clinical study.
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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: Telerehabilitation (Other)
Control group
CG participants followed the exercise program and trained at home with images and videos as support.
Intervention: Exercise program (Other)
Outcomes
Primary Outcomes
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
- Maximal Strength.(Twenty weeks.)
- Strength endurance.(twenty weeks.)
- Endurance capacity.(Twenty weeks)
- Maximal Strength.(Ten weeks.)
- Strength endurance.(Baseline)
- Endurance capacity.(Baseline.)
- Strength endurance.(ten weeks)
- Endurance capacity.(ten weeks)