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Clinical Trials/NCT05469568
NCT05469568
Active, not recruiting
Not Applicable

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

Brno University Hospital1 site in 1 country50 target enrollmentJuly 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Brno University Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change from Baseline Movement skills score at 12 weeks and 6 months
Status
Active, not recruiting
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
December 30, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Brno University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ladislav Batalik

Principal Investigator

Brno University Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change from Baseline Movement skills score at 12 weeks and 6 months

Time Frame: Baseline, 12 weeks, 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.

Secondary Outcomes

  • Change from Baseline Walking skills score at 12 weeks and 6 months(Baseline, 12 weeks, 6 months)
  • Change from Baseline Depression score at 12 weeks and 6 months(Baseline, 12 weeks, 6 months)
  • Change from Baseline Health related quality of life score at 12 weeks and 6 months(Baseline, 12 weeks, 6 months)
  • Exercise adherence(6 months)

Study Sites (1)

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