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- Ensaio Clínico NCT07677969
The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation
This observational study aims to examine the relationship between the percentage of limb loss and functional outcomes in individuals with unilateral upper limb amputation. Upper limb amputation can affect posture, balance control, pain levels, daily living activities, hand function, and reaction time. However, limited research has investigated how the amount of limb loss influences these outcomes.
Participants between 18 and 65 years of age who use a myoelectric or bionic prosthesis will undergo a series of assessments. These assessments include measurements of postural control using a force platform, posture analysis, evaluation of neck and low back pain using a visual analog scale, daily living activities using a validated questionnaire, hand dexterity using the Box and Block Test, and reaction time using a visual stimulus device.
The study does not involve any intervention or treatment. All evaluations will be performed during a single assessment session. The results of this study may help improve rehabilitation planning and provide better understanding of functional changes associated with different levels of limb loss in people with upper limb amputation.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: ASLI BEBEK, MSc
- Número de telefone: +905364037230
- E-mail: aslisabanci97@gmail.com
Locais de estudo
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Ankara, Turquia (Türkiye)
- Recrutamento
- Hacettepe University
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Contato:
- aslı bebek, MSc
- Número de telefone: +905364037230
- E-mail: aslisabanci97@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Adults aged 18-65 years
- Unilateral upper limb amputation
- Use of a myoelectric or bionic prosthesis for at least 1 year
- Current prosthesis use for a minimum of 3 months
Exclusion Criteria:
- Bilateral upper limb amputation
- Additional amputation of another limb
- Use of passive or cosmetic prosthesis
- Presence of neurological or other significant orthopedic disorders unrelated to amputation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Unilateral Upper Limb Amputation Group
Participants in this cohort are adults aged 18 to 65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Individuals must have been using their current prosthesis for at least three months and have a minimum of one year of prosthesis experience. Participants with additional neurological or orthopedic conditions, bilateral amputation, or passive/cosmetic prosthesis use are excluded. This is an observational study. No interventional procedures are performed. All participants undergo a single assessment session including measurements of postural control, posture, neck and low back pain, daily living activities, hand dexterity, and reaction time. |
This is an observational study.
No interventional procedures are performed.
All assessments are non-invasive measurements.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Daily living activity score
Prazo: through study completion, an average of 1 year
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In upper extremity amputees, daily living activities and occupational skills will be assessed using a questionnaire.
(0-100 score, Survey on Activities of Daily Living and Occupations of Upper Extremity Amputees)
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through study completion, an average of 1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postural Sway and Limits of Stability
Prazo: through study completion, an average of 1 year
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Postural sway (cm) measured using a force BERTEC platform system.
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through study completion, an average of 1 year
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Postural Sway and Limits of Stability
Prazo: through study completion, an average of 1 year
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limits of stability (%) measured using a force BERTEC platform system.
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through study completion, an average of 1 year
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Neck and Back Pain Intensity
Prazo: through study completion, an average of 1 year
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Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
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through study completion, an average of 1 year
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Hand Dexterity
Prazo: through study completion, an average of 1 year
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easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
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through study completion, an average of 1 year
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Reaction Time
Prazo: through study completion, an average of 1 year
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Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FTREK25/28
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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