- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05182411
Validity and Reliability of Turkish Version Leg Activity Measure
Patient-filled scales minimize the burden of data collection for clinicians in a clinical setting.
Therefore, Leg activity measure, a new self-report measure of active and passive function in the leg, has been developed.
Leg activity measure consists of three parts. The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
It is a valid and reliable test in adult neurological patients with lower extremity spasticity. It can be used in the evaluation of the active and passive functions of the results of the clinicians' interventions by making the cultural adaptation of the Turkish language and examining its validity and reliability. We think that it will be important to determine the limitations in activity, participation and daily living activities and to evaluate their reflections.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Spasticity is a common symptom resulting from stroke, brain trauma, and degenerative brain diseases. Spasticity, known as rate-dependent resistance to passive movement, prevents many activities of daily living. Lower extremity spasticity, on the other hand, hinders joint movements and complicates mobility, transfer and passive activities of caregivers.
Goals for the treatment of spasticity often focus on active function improvements in walking, standing, and moving from different sitting positions. However, improvements in passive function tasks and symptom management are often equally important to patients. Active function is the use of the limb to directly perform a task. Passive fonskyion is care of the affected extremity, usually performed by the person himself, but may require assistance from another person.
There is a need for instruments with demonstrable measurement properties that can reflect a clinically significant change in practice. Outcomes developed for treatments such as botulinum toxin and physical interventions for spasticity aimed at improving any aspect of functional performance (active and passive function) should ideally reflect real-life function as opposed to simply observed tasks in the clinical setting.
Leg activity measure filled by the patient consists of three parts. The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
It is a valid and reliable test in adult neurological patients with lower extremity spasticity. It can be used in the evaluation of the active and passive functions of the results of the clinicians' interventions by making the cultural adaptation of the Turkish language and examining its validity and reliability.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Kahramanmaraş, Pavo
- Kahramanmaras Sutcu Imam University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 1 or more spasticity in at least one muscle according to the Modified Ashworth Scale
- Be between the ages of 18-65
- Volunteering to participate in the study
Exclusion Criteria:
- Under 18 years old, over 65 years old
- History of trauma in the last 1 year
- Having alcohol and substance abuse
- Having a pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients with spasticity
adult neurological patients with spasticities in their lower extremities
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Turkish version of Leg Activity Measure Rivearmead Mobility Index Nottingham Health Profile Functional Independence Measures
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Turkish version of Leg Activity Measure
Periodo de tiempo: First day
|
Leg activity measure consists of three parts.
The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
The questions in each section are scored between 0-4.
An increase in the score indicates that the activity could not be performed.
|
First day
|
|
Turkish version of Leg Activity Measure
Periodo de tiempo: 2 weeks later
|
Leg activity measure consists of three parts.
The first part includes passive functions, the second part includes active functions, and the third part includes the assessment of quality of life.
The questions in each section are scored between 0-4.
An increase in the score indicates that the activity could not be performed.
|
2 weeks later
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Rivermead Mobility Index
Periodo de tiempo: First day
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The Rivermead Mobility Index is appropriate for a range of disabilities that include anything from being bedridden to being able to run
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First day
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Nottingham Health Profile (NHP)
Periodo de tiempo: First day
|
The NHP is a patient-reported questionnaire. Respondents tick yes or no boxes to answer questions about their health and its effects on their daily life. The questionnaire is divided into two parts. The first parts comprises 38 questions in six categories: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. The second part of the NHP is made up of seven statements about areas of life that are commonly affected by health: paid employment, jobs around the house, social life, personal relationships, sex life, hobbies and interests, and holidays |
First day
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The Functional Independence Measure (FIM)
Periodo de tiempo: First day
|
The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. |
First day
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades autoinmunes
- Heridas y Lesiones
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Esclerosis múltiple
- Lesiones de la médula espinal
Otros números de identificación del estudio
- ipekkkirmaci
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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