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

NCT05469568 | Active Not Recruiting

• 1 other identifier: Hybrid rehabilitation approach
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Telerehabilitation; Circuit Training; Movement Skills; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from Baseline Depression score at 12 weeks and 6 months

  Baseline, 12 weeks, 6 months

• Change from Baseline Walking skills score at 12 weeks and 6 months

  Baseline, 12 weeks, 6 months

• Exercise adherence

  6 months

• Change from Baseline Health related quality of life score at 12 weeks and 6 months

  Baseline, 12 weeks, 6 months

Study Arms (2)

Circuit training and telerehabilitation

EXPERIMENTAL

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

Usual Care

SHAM COMPARATOR

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

Interventions

Circuit training followed by telerehabilitation OTHER

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.

Circuit training and telerehabilitation

Usual care OTHER

Patients have usual information about importance of regular movement activities and recommendation of proper exercises

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Michaela Sládečková

Brno, Czech Republic, 625 00, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ladislav Batalik

  Department of Rehabilitation, University Hospital Brno, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 21, 2022
• Study Start: July 15, 2022
• Primary Completion: September 26, 2025
• Study Completion: December 30, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CZ (1)