- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04521270
Financial Burden Associated With Stroke Rehabilitation
Přehled studie
Postavení
Podmínky
Detailní popis
Stroke is a clinical syndrome characterized by the rapid onset of focal neurological signs, lasting more than 24 hours or leading to death, with a presumed vascular cause. The main causes of stroke is it occur due to infarction and due to hemorrhage. In the U.S, approximately 40 percent of people who die from stroke are male, with 60 percent of deaths occurring in females. Worldwide, cerebro-vascular accidents (stroke) are the second leading cause of death and the third leading cause of disability. Stroke, the sudden death of some brain cells due to lack of oxygen when the blood flow to the brain is lost by blockage or rupture of an artery to the brain, is also a leading cause of dementia and depression. Globally, 70% of strokes and 87% of both stroke-related deaths and disability-adjusted life years occur in low- and middle-income countries. Over the last four decades, the stroke incidence in low- and middle-income countries has more than doubled. During these decades stroke incidence has declined by 42% in high-income countries.
The incidence of a stroke increases rapidly with age, doubling every decade after 55 years old. There are various risk factors for stroke, including both modifiable (e.g., diet, co-morbid conditions) and non-modifiable risk factors (e.g., age, race).Other risk factors which is short-term risks or triggers (e.g., infectious events, sepsis, stress), intermediate- term risk factors (e.g., hypertension, hyperlipidemia) and long-term risk factors for stroke (e.g., sex, race). Risk factors for stroke in the young also likely differ from those in older patients. Recovery and rehabilitation is the most important aspects of stroke treatment. In most strokes cases the patient recover quickly, and sometimes patient recovery is variable. Rehabilitation process includes physical therapy, speech therapy and occupational therapy. Physical therapy involves using exercise and other physical means (e.g., massage, heat) and may help patients to regain their ROM and use of their arms and legs and prevent muscle stiffness in patients or with permanent paralysis. Speech therapy may help patients regain the ability to speak. Occupational therapy may help patients regain independent function and re-learn basic skills (e.g., Getting dressed, preparing a meal and bathing). Stroke is a common, serious, and disabling global health-care problem, and rehabilitation is a major part of patient care.Potentially beneficial treatment options for motor recovery of the arm include constraint-induced movement therapy and robotics. Most favorable interventions that could be beneficial to improve aspects of gait include fitness training, high-intensity therapy, and repetitive-task training.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Punjab
-
Lahore, Punjab, Pákistán, 54000
- Riphah International University
-
Lahore, Punjab, Pákistán, 54770
- Riphah Rehabiliation Clinic
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Stroke diagnosed by computerized axial tomography or a magnetic resonance imaging scan.
- Willing to give Informed consent
- Discharged from a rehabilitation hospital
Exclusion Criteria:
- Pre existing Physical or Psychiatric disabilities ( e.g. , Dementia, Multiple Sclerosis, Parkinson's Disease)
- Previous Stroke or Aphasia
- A patient with Reduced level of Consciousness
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Structured Questionnaire
Časové okno: 6 Months
|
A questionnaire that consisted of three sections:
|
6 Months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Modified Charlson Co-morbidity Index
Časové okno: 6 Months
|
The use of comorbidities for prognostic assessment has been extensively studied in other fields of medicine.
One of the most commonly used comorbidity models is the Charlson Comorbidity Index (CCI), which is based on comorbid conditions with varying assigned weights, resulting in a composite score.
|
6 Months
|
|
Barthel Index (BI)
Časové okno: 6 Months
|
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.
The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL
|
6 Months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Luengo-Fernandez R, Paul NL, Gray AM, Pendlebury ST, Bull LM, Welch SJ, Cuthbertson FC, Rothwell PM; Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke. 2013 Oct;44(10):2854-61. doi: 10.1161/STROKEAHA.113.001584. Epub 2013 Aug 6.
- Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28.
- Luengo-Fernandez R, Gray AM, Rothwell PM; Oxford Vascular Study. A population-based study of hospital care costs during 5 years after transient ischemic attack and stroke. Stroke. 2012 Dec;43(12):3343-51. doi: 10.1161/STROKEAHA.112.667204. Epub 2012 Nov 15.
- Tyagi S, Koh GC, Nan L, Tan KB, Hoenig H, Matchar DB, Yoong J, Finkelstein EA, Lee KE, Venketasubramanian N, Menon E, Chan KM, De Silva DA, Yap P, Tan BY, Chew E, Young SH, Ng YS, Tu TM, Ang YH, Kong KH, Singh R, Merchant RA, Chang HM, Yeo TT, Ning C, Cheong A, Ng YL, Tan CS. Healthcare utilization and cost trajectories post-stroke: role of caregiver and stroke factors. BMC Health Serv Res. 2018 Nov 22;18(1):881. doi: 10.1186/s12913-018-3696-3.
- Luengo-Fernandez R, Yiin GS, Gray AM, Rothwell PM. Population-based study of acute- and long-term care costs after stroke in patients with AF. Int J Stroke. 2013 Jul;8(5):308-14. doi: 10.1111/j.1747-4949.2012.00812.x. Epub 2012 May 9.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- REC/Lhr/20/2028 Rimsha Tariq
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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 .