Approche de réadaptation hybride par exercice de groupe et téléréadaptation chez les patients atteints de sclérose en plaques
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Czech Republic
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Brno, Czech Republic, Tchéquie, 625 00
- Michaela Sládečková
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
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. |
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Comparateur factice: 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 |
Patients have usual information about importance of regular movement activities and recommendation of proper exercises |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline Movement skills score at 12 weeks and 6 months
Délai: Baseline, 12 weeks, 6 months
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline Depression score at 12 weeks and 6 months
Délai: Baseline, 12 weeks, 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
|
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Change from Baseline Walking skills score at 12 weeks and 6 months
Délai: Baseline, 12 weeks, 6 months
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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
|
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Exercise adherence
Délai: 6 months
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Number of added movement activities in application. Higher scores mean better adherence to exercise. |
6 months
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Change from Baseline Health related quality of life score at 12 weeks and 6 months
Délai: Baseline, 12 weeks, 6 months
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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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ladislav Batalik, Department of Rehabilitation, University Hospital Brno, Czech Republic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Hybrid rehabilitation approach
Informations sur les médicaments et les dispositifs, documents d'étude
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