- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ASLI BEBEK, MSc
- Número de teléfono: +905364037230
- Correo electrónico: aslisabanci97@gmail.com
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Reclutamiento
- Hacettepe University
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Contacto:
- aslı bebek, MSc
- Número de teléfono: +905364037230
- Correo electrónico: aslisabanci97@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Daily living activity score
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postural Sway and Limits of Stability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FTREK25/28
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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