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Does Prolonged Sitting Pressure Affect Sitting Pressure, Flexibility and Discomfort? ((wheelchair))

10. února 2021 aktualizováno: Fatma Erdeo, Necmettin Erbakan University

Assessment of Wheelchair First and Last Seating Pressure and Posture and Wheelchair Satisfaction

ntroduction: Pressure sores and postural changes are observed in wheelchair users due to long sitting. Depending on this situation, the quality of life and activity participation level of these individuals decrease.

Method: This study will be conducted between March 1 and June 30, 2021 in Necmettin Erbakan University, Meram Faculty of Medicine, Physical Therapy and Rehabilitation Polyclinic. With the hamstring and trunk flexibility sit-lie test, six sensors placed on the sitting pressure sitting cushion, daily life activity FIM, skill assessment tests will be applied for manual and wheelchair users. Wheelchair Satisfaction CHART and quality of life World Health Organization Quality of Life (Whool ) will be evaluated with.

Application: Patients coming to the center spend 20 minutes on MAT. After resting, FIM will be evaluated with the sit-and-lie test. Afterwards, the patient will be put in a wheelchair. The initial sitting pressure will be taken as soon as you sit in the wheelchair. And at that time, CHART and WHOOL will be completed by asking the patient.

Conclusion: In the light of these evaluations, the change in initial sitting pressure and posture over time will be examined.

Přehled studie

Postavení

Neznámý

Detailní popis

HH.3. Scope:

Which is about 12.29% of the population consists of disabled people in Turkey and the highest rate of disability It is known that physical disability (1). Having at least one wheelchair of approximately 75 million worldwide according to 2019 data plays a critical role in improving mobility (2). In fact, the wheelchair is one of the most widely used assistive technology tools to increase personal mobility and is a precondition for those with limited mobility to enjoy their human rights, live in dignity and become more productive members in their community. For many people, a well-designed and well-equipped wheelchair can be the right step for social inclusion (3). More than half of wheelchair users need assistance with using their wheelchairs and daily living activities (4). The literature investigating the factors affecting wheelchair use mainly consists of variables related to the environment and physical characteristics of wheelchair users (4). Correct selection and configuration of wheelchairs can increase mobility, effectiveness and participation (5).

While sitting comfort is associated with softness and support, lack of support, unbalanced pressure distribution, biomechanics and fatigue factors are associated with sitting discomfort. Anatomical factors can cause characteristic tissue loads that appear to be associated with tissue damage, discomfort, or axillary posture or movement modifications. Following excessive or prolonged tissue loading, cell death may lead to the development of superficial or deep compression wounds (6). A superficial pressure sore first affects the skin layers near the epidermal tissue and is typically associated with damaging friction and shear forces with the presence of moisture and heat (7). Deep compression sores typically begin with the deformation of deep muscle and fat tissues beneath the ischial tuberocytes in the sitting position (8). Although the etiology of pressure sores is multifactorial (9), continuous pressure at the user seat interface is considered the most important factor (10,11). Therefore, wheelchair features are very important for posture and pressure sores. In our study, wheelchair features will be examined and these features will be compared with patient satisfaction. In addition, wheelchair characteristics and patient satisfaction in different patient groups (such as spinal cord injury, Multiple Sclerosis, Cerebrovascular Incident (stroke)) will also be discussed.

Hypotheses Ho: There is no difference between initial sitting pressure and posture in wheelchair users and sitting pressure and posture after 2 and 3 hours.

H1: There is a difference between the initial sitting pressure and posture in wheelchair users and the sitting pressure and posture after 2 and 3 hours.

H2: There is a difference between the initial sitting pressure and posture and the sitting pressure and posture after 2 and 3 hours in different patient groups.

H.4. Method: Individuals Patients who are being followed up in FTR or neurology Neurology clinics at Necmettin Erbakan University Meram Faculty of Medicine will be included in the study. In the G-Power analysis we conducted, Cascioli's study was based on comfort (12). However, we think that the number of people to be included in the study is low in terms of objectivity of the data. For this reason, a preliminary study will be conducted during the study and the sample number will be confirmed.

  1. Physical characteristics and history taking: Patients will be asked in detail about age, height, weight, disease diagnosis and duration, and wheelchair characteristics.

    Inclusion criteria were:

    1. Patients with multiple sclerosis, myopathies, amyotrophic lateral sclerosis, polio and medulla spinalis incision,
    2. Being 18 years of age or older,
    3. have used a wheelchair for at least three months,
    4. being dependent on a wheelchair (all day) or at certain times of the day as the primary means of movement, Individuals will be excluded if they have suffered pressure sores within the last year.
  2. Evaluations After taking the patient's history, the person was taken to MAT bed for 20 minutes. will be provided to rest. 20 minutes At the end, the patient who passes to the wheelchair will be asked to evaluate the comfort and discomfort they perceived after the first contact in the chair as 0 (none) -10 (very bad). Grading will be asked to evaluate the discomfort in the head, neck, back, waist, hips and legs, not the general sense of comfort. Meanwhile, pressure and posture will be evaluated.

    • Route-Reach test: This test is used to evaluate hamstring and trunk flexion flexibility. The subject will be asked to sit on the test table with both knees in extension on a firm surface and reach out with his hands and feet without bending the knees. The distance between the fingers and the tip of the test table is measured with a ruler

Typ studie

Pozorovací

Zápis (Očekávaný)

15

Kontakty a umístění

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

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

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

N/A

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

Patients who are being followed up in FTR or neurology Neurology clinics at Necmettin Erbakan University Meram Faculty of Medicine will be included in the study. In the G-Power analysis we conducted, the analysis was made based on comfort data in Cascioli's study (12). However, we think that the number of people to be included in the study is low in terms of objectivity of the data. For this reason, a preliminary study will be conducted during the study and the sample number will be determined.

Popis

Inclusion Criteria:

Patients with multiple sclerosis, myopathies, amyotrophic lateral sclerosis, polio and medulla spinalis incision, Being 18 years of age or older, have used a wheelchair for at least three months being dependent on a wheelchair as a primary mobility (all day) or at certain times of the day -

Exclusion Criteria:

Individuals will be excluded if they have suffered pressure sores within the past year.

-

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Assessment of Wheelchair First-Last Seating Pressure and Posture and Wheelchair Satisfaction
Časové okno: 45 minutes
All af study
45 minutes
Sit-Reach test: Pressure Rating: It will be evaluated in kilograms
Časové okno: 2 two minutes
the value will be recorded in centimeters (cm).
2 two minutes
Pressure Rating
Časové okno: 3 minutes
It will be evaluated in kilograms
3 minutes

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Evaluation of basic daily living activities (FIM)
Časové okno: 10 minutes
The total FIM score can range from 18-126.
10 minutes
Craig Handicap Assessment and Reporting Technique (CHART)
Časové okno: 10 minutes
Has a scale score ranging from 0 to 100
10 minutes
Wheelchair Skills Test (WST) for manual wheelchair users
Časové okno: 15 minutes
Total WST Capacity Score = total of individual skill points / ([number of possible skills - number of NP points - number of TE points] x 3) X 100%
15 minutes
World Health Organization Quality of Life Scale (WHOQOL):
Časové okno: 5 minutes
WHOQOL-BREF, unlike the long scale, consists of 4 domains. They do not have separate sections. This scale also has no total score. Each section and area scores a maximum of 20 points or 100 points
5 minutes

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Fatma Erdeo, Phd, Necmettin Erbakan University
  • Ředitel studie: Sami Küçükşen, Prof., Necmettin Erbakan University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

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 (Očekávaný)

1. března 2021

Primární dokončení (Očekávaný)

30. června 2021

Dokončení studie (Očekávaný)

30. srpna 2021

Termíny zápisu do studia

První předloženo

3. února 2021

První předloženo, které splnilo kritéria kontroly kvality

10. února 2021

První zveřejněno (Aktuální)

11. února 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. února 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. února 2021

Naposledy ověřeno

1. února 2021

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • NecmettinNEU

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

When the research is published, I will share my data over Mendeley data sharing.

Časový rámec sdílení IPD

1 year

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

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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