The Effect of Home-Based Telerehabilitation in Individuals With Stroke
8. oktober 2021 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Recep Ormen, M.Sc
- Telefonnummer: +905316777334
- E-post: rormen@gmail.com
Studiesteder
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Bakirkoy
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Istanbul, Bakirkoy, Tyrkia, 34100
- Rekruttering
- Istanbul University-Cerrahpaşa
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Underetterforsker:
- Yonca Zenginler Yazgan, PhD
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Ta kontakt med:
- Recep Ormen, M.Sc
- Telefonnummer: +905316777334
- E-post: rormen@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
|
|
Eksperimentell: Control Group
This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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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.
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Baseline and end of weeks 8
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Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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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.
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Baseline and end of weeks 8
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Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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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.
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Baseline and end of weeks 8
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Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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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.
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Baseline and end of weeks 8
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Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.
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Baseline and end of weeks 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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It is a 14-item scale that measures the patient's confidence in falling.
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Baseline and end of weeks 8
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WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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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.
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Baseline and end of weeks 8
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Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
Tidsramme: Baseline and end of weeks 8
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It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
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Baseline and end of weeks 8
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Global Rating of Change Scales
Tidsramme: End of weeks 8
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It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
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End of weeks 8
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System Usability Scale
Tidsramme: End of weeks 8
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It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
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End of weeks 8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Yonca Zenginler Yazgan, PhD, Istanbul University-Cerrahpasa Faculty of Health Science
- Hovedetterforsker: Recep Ormen, M.Sc, Istanbul University-Cerrahpasa Institute of Postgraduate Education
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. oktober 2021
Primær fullføring (Forventet)
4. august 2022
Studiet fullført (Forventet)
28. desember 2022
Datoer for studieregistrering
Først innsendt
8. oktober 2021
Først innsendt som oppfylte QC-kriteriene
8. oktober 2021
Først lagt ut (Faktiske)
19. oktober 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2021
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IUC-2021/62
Legemiddel- og utstyrsinformasjon, studiedokumenter
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