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The Effect of Home-Based Telerehabilitation in Individuals With Stroke

8 oktober 2021 bijgewerkt door: Recep Ormen, Istanbul University - Cerrahpasa (IUC)

The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke

Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.

In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Recep Ormen, M.Sc
  • Telefoonnummer: +905316777334
  • E-mail: rormen@gmail.com

Studie Locaties

  • Kalkoen
    • Bakirkoy
      • Istanbul, Bakirkoy, Kalkoen, 34100
        • Werving
        • Istanbul University-Cerrahpasa
        • Onderonderzoeker:
          • Yonca Zenginler Yazgan, PhD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Diagnosed with stroke at least 1 year ago by a neurologist
  • Modified Rankin score ≤3
  • Have an internet infrastructure that can be accessed at home
  • Not participated in a standardized physiotherapy program in the past 3 months

Exclusion Criteria:

  • Presence of blurred or low vision problems
  • Hearing and speech impairment at a level that will affect participation in the system
  • Epilepsy
  • Presence of pregnancy
  • Having any cognitive problems that prevent using the system

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Telerehabilitation Group
This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.
Ander: Home-based Telerehabilitation
Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
Experimenteel: Control Group
This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.
Ander: Exercise Brochure
Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Baseline and end of weeks 8
Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
Baseline and end of weeks 8
Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
Baseline and end of weeks 8
Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Baseline and end of weeks 8
Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.
Baseline and end of weeks 8

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
It is a 14-item scale that measures the patient's confidence in falling.
Baseline and end of weeks 8
WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
It is a health-related quality of life scale developed by the World Health Organization. A national question was added to the Turkish version of the scale in addition to the original version.
Baseline and end of weeks 8
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
Tijdsspanne: Baseline and end of weeks 8
It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
Baseline and end of weeks 8
Global Rating of Change Scales
Tijdsspanne: End of weeks 8
It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
End of weeks 8
System Usability Scale
Tijdsspanne: End of weeks 8
It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
End of weeks 8

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Onderzoekers

  • Studie stoel: Yonca Zenginler Yazgan, PhD, Istanbul University-Cerrahpasa Faculty of Health Science
  • Hoofdonderzoeker: Recep Ormen, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 oktober 2021

Primaire voltooiing (Verwacht)

4 augustus 2022

Studie voltooiing (Verwacht)

28 december 2022

Studieregistratiedata

Eerst ingediend

8 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

8 oktober 2021

Eerst geplaatst (Werkelijk)

19 oktober 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 oktober 2021

Laatste update ingediend die voldeed aan QC-criteria

8 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IUC-2021/62

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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