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The Effects of Respiratory-based Telerehabilitaion in Patients With MS (MS)

12. května 2021 aktualizováno: Dr. Anıl Tosun

The Effects of Respiratory-based Telerehabilitation on Physical Performance and Factors Affecting Compliance in Patients With Multiple Sclerosis

During the pandemic, it is important for people who are isolated in their homes to stay inactive and exercise exercises in order to prevent their complaints from increasing due to inactivity. Individuals with multiple sclerosis are outpatient or inpatient with home exercise programs besides the rehabilitation practices. They are being monitored. It has been reported the rehabilitation of individuals is that they need to comply with their home exercise programs in order to contribute. However, very limited research studies suggest that any method can be used as home exercise has examined whether it has increased compliance with the program. However, examining the factors affecting the compliance of individuals with Multiple sclerosis to the home exercise program. The study was not found either.

Exercise through tele-rehabilitation in individuals with multiple sclerosis in previous studies where their education contributed to the physical performance of patients shown. However, these studies are based on individual neurorehabilitation models. In the literature, the use of video-based exercise training in MS patients a study showing increased performance as well as increased participation in the home program available. However, in this study, a special program was applied to the individual and it is not a respiration-based program. There is no research on web-based group activity training in the field.

Přehled studie

Detailní popis

Multiple sclerosis is chronic and improves the quality of life of the person is a neurological disease that decreases. Multiple Sclerosis in mobility and functional activities cause restrictions in social and professional life, leading to different degrees of disability. It is a disease that causes severe disability and impairs the quality of life. MS, It is one of the most common diseases that cause disability, usually between the ages of 15-50. In recent years, combating disability caused by MS is the most important and has been the main focus. Patients' life expectancy is gradually increasing, One of the important reasons for this is symptomatic treatments and modern rehabilitation. It is said to have applications.

Depression affects approximately 50% of patients with MS. The social isolation caused by quarantine may have increased depression. In MS, in combating spasticity, as well as depression and chronic fatigue, regular exercise is important.

During the pandemic, it is important for people who are isolated in their homes to stay inactive and exercise exercises in order to prevent their complaints from increasing due to inactivity. Individuals with multiple sclerosis are outpatient or inpatient with home exercise programs besides the rehabilitation practices. They are being monitored. It has been reported the rehabilitation of individuals is that they need to comply with their home exercise programs in order to contribute. However, very limited research studies suggest that any method can be used as home exercise has examined whether it has increased compliance with the program. However, examining the factors affecting the compliance of individuals with Multiple sclerosis to the home exercise program. The study was not found either.

Exercise through tele-rehabilitation in individuals with multiple sclerosis in previous studies where their education contributed to the physical performance of patients shown. However, these studies are based on individual neurorehabilitation models. In the literature, the use of video-based exercise training in MS patients a study showing increased performance as well as increased participation in the home program available. However, in this study, a special program was applied to the individual and it is not a respiration-based program. There is no research on web-based group activity training in the field.

Typ studie

Intervenční

Zápis (Očekávaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Istanbul, Krocan, 34758
        • Fenerbahce University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria: ambulatuar or non -ambulatuar

  • All patients with diagnosed with Multiple Sclerosis. (Diagnosis of MS according to the revised McDonald Criteria 2017)
  • An ability to understand and execute simple instructions.
  • Aged 20-65 years old.

Exclusion Criteria:

  • patients with hearing, vision and cognitive problems.
  • Pregnancy (self-reported)
  • Orthopedic and other neurological disorders affecting upper limb movements (e.g., epileptic seizures)
  • Contra-indication to physical activity (e.g., heart failure, severe osteoporosis) MS clinical relapse or treatment with corticosteroid therapy within 30 days prior to enrollment
  • Started or stopped a disease-modifying therapy for MS within 30 days prior to enrollment

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: telerehabilitation
pre-post telerehabilltation
web based telerehablitation
Ostatní jména:
  • telerehabilitation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Barthell Scale
Časové okno: 1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline BI score at 1 month after the program start. 3rd assesment: Change from baseline BI score at 2 month after the program start
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. Time to administer- Self report: 2-5 minutes; Direct observation: 20 minutes. Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Barthel scores are that scores of 0-20 indicate "total" dependency and 91-99 indicates "slight" dependency.
1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline BI score at 1 month after the program start. 3rd assesment: Change from baseline BI score at 2 month after the program start
Functional Ambulatation Categories
Časové okno: 1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline FAC score at 1 month after the program start. 3rd assesment: Change from baseline FAC score at 2 month after the program start.
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Functional Ambulation Classification (FAS): FAS is a valid and reliable scale that evaluates the physical support needed during walking over 6 scores between 0 and 5. It is scored according to the support needed by the patient through observation. Accordingly, the scores; 0- It cannot be ambulatory alone, except for the parallel bar, the patient needs the help of at least 2 people in order to be ambulatory. 5- It walks independently on all floors.
1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline FAC score at 1 month after the program start. 3rd assesment: Change from baseline FAC score at 2 month after the program start.
Fatigue Severity Scale
Časové okno: 1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline FSS score at 1 month after the program start. 3rd assesment: Change from baseline FSS score at 2 month after the program start
The Fatigue Severity Scale (FSS) is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. Essentially, the FSS consists of answering a short questionaire that requires the subject to rate his or her own level of fatigue. The obvious problem with this measure is its subjectivity.A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer.
1st assesment: At first day (baseline avaluation); 2nd assesment: Change from baseline FSS score at 1 month after the program start. 3rd assesment: Change from baseline FSS score at 2 month after the program start

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Studijní židle: Anıl Tosun, Dr., Fenerbahce University
  • Ředitel studie: Hilal Keklicek, Asc.Prof., Trakya University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. dubna 2021

Primární dokončení (Očekávaný)

30. června 2021

Dokončení studie (Očekávaný)

30. srpna 2021

Termíny zápisu do studia

První předloženo

18. dubna 2021

První předloženo, které splnilo kritéria kontroly kvality

12. května 2021

První zveřejněno (Aktuální)

14. května 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. května 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. května 2021

Naposledy ověřeno

1. května 2021

Více informací

Termíny související s touto studií

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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