Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis

The aim of the study is to determine the benefits of outpatient group rehabilitation with subsequent telerehabilitation. The patient will participate in a 12-week circuit training, including training once a week in a group of six under the guidance of two physiotherapists. After the outpatient rehabilitation, the patient will gain access to a mobile application and will be asked to record all physical activities there.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Circuit training followed by telerehabilitation; Other: Usual care

Detailed Description

In the Czech population more than 20,000 people have been diagnosed with multiple sclerosis (MS), an autoimmune disease affecting a patient's central nervous system. This disease has a wide range of symptoms, with the most common ones being various motor disorders that negatively affect the locomotor function and patients' quality of life.

The positive effect of physical activity on human health is well known. This study aims to examine the effect of hybrid exercise program on people with MS. This exercise program includes ambulatory circuit training for twelve weeks followed by telerehabilitation. The aim of the study is to find out whether the exercise program will positively affect the movement skills of probands and improve their quality of life. Testing will done before the start of the exercise program, after twelve weeks and after 6 months. Movement skills will be tested by a set of movement tests called miniBEST test. For measuring quality of life the investigators will the SF-36 questionnaire will be used. Another goal will analyze participants' satisfaction with the intervention and adherence to regular physical activity.

The investigators anticipate that regular physical training combined with telerehabilitation will increase the motivation and effectiveness of independent training in people with MS leading to improvment of physical fitness, physical activity levels and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Czech Republic
    • Brno, Czech Republic, Czechia, 625 00
      • Michaela Sládečková

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria
• Minimal one month from last relapse
• Possibility to use smartphone or tablet because of using rehabilitation application

Exclusion Criteria:

• Illnesses which can limiting exercises activities (e.g. orthopedic, cardiology or other neurological diseases)
• Cognitive deficit which can limiting cooperation (fill a questionnaire, comply with movement task, using application)
• Relapse of diseases during study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Circuit training and telerehabilitation; The experimental group will participate in a 12-week rehabilitation program, including training once a week. After the end of this outpatient program, participants will gain access to a mobile application in which participants will record all their physical activities.The mobile application will also include a library of exercises taught during the outpatient program so patients can practice them at home.	Other: Circuit training followed by telerehabilitation; Patients participate in an ambulatory rehabilitation program (12 weeks) and then gain access to mobile application to record their movement activities. This application will aslo inlude a library with exercise vidoes from the ambulatory program. These videos should inspire patients to do the exercises at home.
Sham Comparator: Usual Care; Patients have usual care and usual information about importance of regular movement activities and recommendation of proper exercises. Patients don't visit ambulatory rehabilitation program and they don't have access to an application	Other: Usual care; Patients have usual information about importance of regular movement activities and recommendation of proper exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Movement skills score at 12 weeks and 6 months	Mini Balance Evaluation Systems Test (Mini BESTest) - 14-item scale for measure postural stability. Maximum value is 28 points, minimum value is 0 point. Higher scores mean a better outcome.	Baseline, 12 weeks, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Depression score at 12 weeks and 6 months	Beck's Depression Inventory (BDI) - 21-item, self-report rating. Maximum value is 63 points, minimum value is 0 point. Higher scores mean a worse outcome.	Baseline, 12 weeks, 6 months
Change from Baseline Walking skills score at 12 weeks and 6 months	12-Item Multiple Sclerosis Walking Scale - self-report rating. Maximum value is 60 points, minimum value is 12 point. Higher scores mean a worse outcome.	Baseline, 12 weeks, 6 months
Exercise adherence	Number of added movement activities in application. Higher scores mean better adherence to exercise.	6 months
Change from Baseline Health related quality of life score at 12 weeks and 6 months	Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.	Baseline, 12 weeks, 6 months

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Principal Investigator: Ladislav Batalik, Department of Rehabilitation, University Hospital Brno, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): September 26, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Quality of Life; Telerehabilitation; Circuit Training; Movement Skills
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: Hybrid rehabilitation approach

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No