Fear of Fall Related Factors in Chronic Stroke
3 de abril de 2022 atualizado por: Nese Olmez Sarikaya, Izmir Katip Celebi University
Relationship Between Fear of Falling and Balance, Posture, Spasticity and Functional Independence in Chronic Stroke Patients
Some stroke survivors develop a fear of falling(FoF) which may exist with or without a prior fall.
Fear of fall can be defined as decreased perceived self efficacy or confidence in maintaining balance while completing regular activities.
FoF may impair rehabilitation and recovery.
Determination of FoF related factors will help to identify interventions needed to decrease FoF.
Mostly fear of fall related factors have been studied in acute stroke patients, limited data are available for patients with chronic stroke.
The objective of this study is to evaluate frequency of FoF in chronic(>6 months) stroke patients and investigate relationship between FoF and balance, posture,spasticity and activities of daily living.
The Turkish Version of the Modified Falls Efficacy Scale was used to measure FoF.
Also a single-item dichotomous question "Are you afraid of falling?
(Yes/No)" will be asked.
Visão geral do estudo
Descrição detalhada
In this observational study, chronic(>6 months) stroke patients who admitted to Physical Medicine and Rehabilitation outpatient clinic, older than 50 years old will be included.
Sociodemographic and medical data including patients' age, gender, height, weight, body mass index, contact information, marital status, educational status, plegia side, stroke etiology, time after stroke, accompanying diseases, medications used, fear of falling (yes/no), history of falling (yes/no), and the use of walking aids will be recorded.
In the evaluation of patients, Brunnstrom Hemiplegia Recovery Staging, Functional Ambulation Classification (FAC), Mini Mental State Examination(MMSE),Turkish Version of Modified Falls Efficacy Scale(MFES), Berg Balance Scale(BBS), Postural Assessment Scale for Stroke Patient Turkish Version (PASS-Turk), Modified Ashworth Scale (MAS), Modified Barthel Activities of Daily Living Index will be used.
Fear of falling will be evaluated by the same researcher using the MFES.
Also a question " Are you afraid of falling?
(Yes/No)" will be asked.
The patients will be divided into two groups as Group 1 =MFES<5 and Group2 =MFES ≥5.
Balance, posture, ambulation status, spasticity, daily living activities and Brunnstrom staging will be compared between two groups.
Correlation between MFES and balance, posture and activities of daily living will be studied.
Tipo de estudo
Observacional
Inscrição (Real)
50
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
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İzmir, Peru, 35150
- Izmir Katip Celebi University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
Chronic stroke patients, admitted to Izmir Katip Celebi University Ataturk Training and Research Hospital Physical Medicine and Rehabilitation outpatient clinic, aged 50 and older.
Descrição
Inclusion Criteria:
- Patients aged 50 and over
- More than 6 months after the stroke
- Able to follow 3-digit orders
- Able to approve the consent form in writing
- Patients with a score of 23 and above on the Mini-Mental State Test will be included
Exclusion Criteria:
- Bed-dependent, wheelchair-dependent patients
- Patients diagnosed with Alzheimer's, Dementia
- Patients who are cardiovascularly unstable
- Patients with diseases that affect balance (such as Parkinson's disease, Cerebral trauma, Meniere, ear infection, Benign paroxysmal positional vertigo, Multiple sclerosis) and those who use drugs that disrupt the balance
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fear of falling
Prazo: 1 day (All patients will be evaluated once.)
|
Fear of falling will be measured by Turkish Version of Modified Falls Efficacy Scale(MFES).
It is a 14-question scale that evaluates patients' fear of falling and their self-confidence in performing daily living activities.
|
1 day (All patients will be evaluated once.)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Balance
Prazo: 1 day (All patients will be evaluated once.)
|
Balance will be measured by Berg Balance Scale.
It consists of 14 sub-measurements.
Each parameter will be evaluated by scoring between 0-4 and the total score will be revealed.
Patients with a total score of 0-20 were associated with high fall risk, 21-40 moderate fall risk, 41-56 low risk
|
1 day (All patients will be evaluated once.)
|
|
Posture
Prazo: 1 day (All patients will be evaluated once.)
|
Posture will be measured by Postural assessment scale for stroke patients (PASS-Turk).
In the scale, there are a total of 12 parameters, 5 parameters related to maintaining posture and 7 parameters related to posture change.
Each parameter will be scored between 0-3 points and the result will be the PASS-Turk Total score.
|
1 day (All patients will be evaluated once.)
|
|
Functional Independence
Prazo: 1 day (All patients will be evaluated once.)
|
Functional independence will be measured by Modified Barthel Activities of Daily Living Index.
It is an index that evaluates the parameters of transfer, ambulation, going up and down stairs, feeding, dressing, personal care, bathing, sitting and standing on the toilet, urine continence, stool continence and collects patients in 5 groups according to these parameter scores.
In these groups evaluated between 1 and 5, 1; While it was evaluated as insufficient to do business, 5; it is evaluated completely independently.
|
1 day (All patients will be evaluated once.)
|
|
Spasticity
Prazo: 1 day (All patients will be evaluated once.)
|
Spasticity will be measured by Modified Ashworth Scale.
The shoulder girdle, elbow, hand, hip girdle, knee and ankle-ankle joints are scored as 0/1/1 + / 2/3/4 according to the spasticity scale by evaluating the right and left sides separately with speed-dependent passive stretching.
|
1 day (All patients will be evaluated once.)
|
|
Hemiplegia stage
Prazo: 1 day (All patients will be evaluated once.)
|
Hemiplegia stage will be measured by Brunnstrom Hemiplegia Recovery Staging.
This staging consists of 3 sub-headings: Upper extremity, Hand, and lower extremity.
Upper extremity is evaluated from stage 1 to stage 7, hand and lower extremity from stage 1 to stage 6.
|
1 day (All patients will be evaluated once.)
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|
Ambulatory status
Prazo: 1 day (All patients will be evaluated once.)
|
Ambulatory status will be measured by Functional Ambulation Classification.
Classification is evaluated between stage 0 and stage 5. Stage 5 refers to walking fully independently at any speed and on the ground.
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1 day (All patients will be evaluated once.)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Nese Olmez Sarikaya, Prof, Izmir Katip Celebi University
- Investigador principal: Bekir Tetik, MD, Izmir Katip Celebi University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de janeiro de 2021
Conclusão Primária (Real)
1 de fevereiro de 2022
Conclusão do estudo (Real)
1 de fevereiro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
13 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de abril de 2021
Primeira postagem (Real)
14 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de abril de 2022
Última verificação
1 de abril de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Fearoffallstroke
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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