Multiple Sclerosis Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Michaela Sládecková | Brno | Czech Republic |
Lead Sponsor | Collaborator |
---|---|
Brno University Hospital |
Czechia,
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 |
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