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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469568
• Other study ID #: Hybrid rehabilitation approach
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: April 2024
• Source: Brno University Hospital
• Contact: Michaela Sládecková, PT
• Phone: 00420532236337
• Email: sladeckova.michaela[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Usual care
Patients have usual information about importance of regular movement activities and recommendation of proper exercises

Locations

Country	Name	City	State
Czechia	Michaela Sládecková	Brno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Exercise adherence	Number of added movement activities in application. Higher scores mean better adherence to exercise.	6 months
Secondary	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