- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07568951
Impact of Force Control of Hip Abductor Muscles in Healthy Adults and Individuals With Parkinson's Disease
Impact of Force Control of Hip Abductor Muscles on Postural Control in Middle-aged and Older Adults and Individuals With Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Both aging and Parkinson's disease (PD) negatively affect postural control and increase the risk of falls, with frontal plane balance being particularly challenging for these populations. Previous studies have mainly focused on sagittal plane balance and have identified the important roles of ankle plantar flexors and knee extensors; however, the contribution of hip abductor muscles-key muscles for frontal plane stability-remains unclear, particularly in terms of their force production and control abilities. Therefore, this study aims to investigate hip abductor muscle force production and force control, and to examine whether these factors are associated with postural control, gait, and balance performance in individuals across different ages and those with PD. Healthy young, middle-aged, and older adults will be recruited from the community, and individuals with PD will be recruited from the Department of Neurology. Healthy participants must be in good health, able to walk independently, demonstrate normal cognitive function, and provide informed consent, while those with neurological, cardiovascular, musculoskeletal, or other conditions affecting motor performance will be excluded. For individuals with PD, inclusion criteria will be a clinical diagnosis of idiopathic PD, Hoehn and Yahr stages 1 to 3, stable anti-PD medication use, and the ability to follow instructions and walk at least 10 m. Exclusion criteria will include psychiatric, immune, integumentary, or musculoskeletal disorders, neurological conditions other than PD, lower extremity pain, uncontrolled cardiovascular disease, or inability to provide informed consent. All participants will undergo a one-time assessment, including maximal voluntary isometric contraction, force steadiness, postural control, and gait performance.
Surface electromyography will be used to assess neuromuscular function, postural control will be evaluated using a force plate under multiple standing conditions, and gait parameters will be measured at both comfortable and fast walking speeds. Statistical analyses will be conducted using ANOVA to examine group differences.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chu-Ling Yen
- Número de teléfono: 3059 886-3-2118800
- Correo electrónico: clyen@mail.cgu.edu.tw
Ubicaciones de estudio
-
-
-
Taoyuan, Taiwán
- Reclutamiento
- Chang Gung Memorial Hospital
-
Contacto:
- Chu-Ling Yen
- Número de teléfono: 3059 886-3-2118800
- Correo electrónico: clyen@mail.cgu.edu.tw
-
Taoyuan, Taiwán
- Reclutamiento
- Chang Gung University
-
Contacto:
- Chu-Ling Yen
- Número de teléfono: 3059 886-3-2118800
- Correo electrónico: clyen@mail.cgu.edu.tw
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Healthy people
Inclusion Criteria:
- 20 to 39 years (young), 40 to 59 years (young), and 60-85 years (old)
- generally in good health
- able to walk 10 m independently
- able to follow all instructions
Exclusion Criteria:
- neurologic, psychiatric, immune, integumentary, and musculoskeletal diseases or disorders which might influence this study
- any pain over the lower extremities
- uncontrolled cardiovascular diseases
- unable to provide informed consent.
PD
Inclusion Criteria:
- clinical diagnosis of idiopathic PD
- Hoehn and Yahr stages 1 to 3
- stable anti-PD medications
- able to walk 10 m independently
- able to follow all instructions
Exclusion Criteria:
- psychiatric, immune, integumentary, and musculoskeletal diseases or disorders which might influence this study
- neurological conditions other than PD
- any pain over the lower extremities
- uncontrolled cardiovascular diseases
- unable to provide informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Healthy people
General healthy adults
|
We compare the young, middle-aged, and old groups
We compare the healthy group and PD group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Maximal force
Periodo de tiempo: Baseline
|
The maximal force of lower extremity muscles
|
Baseline
|
|
Rate of torque development
Periodo de tiempo: Baseline
|
The ability to rapidly generate muscle force
|
Baseline
|
|
Force steadiness
Periodo de tiempo: Baseline
|
The ability to maintain a constant force output during a submaximal contraction
|
Baseline
|
|
Walking speed
Periodo de tiempo: Baseline
|
The time taken by participants to walk a standardized distance
|
Baseline
|
|
Step Length
Periodo de tiempo: Baseline
|
The linear distance between the two ankles, typically expressed in centimeter(cm).
|
Baseline
|
|
Cadence
Periodo de tiempo: Baseline
|
The number of steps taken per minute (SPM)
|
Baseline
|
|
Single Support Time
Periodo de tiempo: Baseline
|
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.
|
Baseline
|
|
Double Support Time
Periodo de tiempo: Baseline
|
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
|
Baseline
|
|
Swing Time
Periodo de tiempo: Baseline
|
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step.
It is usually expressed as a percentage of the total gait cycle or in seconds.
|
Baseline
|
|
Timed Up-and-Go Test
Periodo de tiempo: Baseline
|
Tthe time an individual takes to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
|
Baseline
|
|
Four Square Step Test
Periodo de tiempo: Baseline
|
Participants will be required to perform four square step test by changing directions while stepping forward, sideway, and backward over a low obstacle as fast as possible.
|
Baseline
|
|
Center of Pressure (COP) Velocity in Balance Tasks
Periodo de tiempo: Baseline
|
The speed at which the COP moves, calculated over the duration of the balance task.
Higher velocities may reflect more dynamic balance adjustments or instability.
Unit:millimeter per second(mm/s)
|
Baseline
|
|
Center of Pressure (COP) Area in Balance Tasks
Periodo de tiempo: Baseline
|
The area covered by the COP trajectory during the balance task, providing an estimate of the sway envelope.
A larger area might indicate poorer balance control.
Unit:square millimeter(mm^2)
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chu-Ling Yen, Chang Gung University
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
- Sinucleinopatías
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Enfermedad de Parkinson
- Fenómeno fisiológico
- Disciplinas y actividades de comportamiento
- Pruebas psicológicas
- Crecimiento y desarrollo
- Pruebas neuropsicológicas
- Estado mental y pruebas de demencia
- Envejecimiento
Otros números de identificación del estudio
- 202202289A3
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Age
-
Centre Hospitalier Saint Joseph Saint Luc de LyonAún no reclutandoInsuficiencia Renal Crónica | Hábito de la dieta | Enfermedad Renal Crónica etapa 3 | Enfermedad renal crónica estadio 3B | Enfermedad renal crónica, etapa 3 (moderada) | Enfermedad renal crónica Etapa 3A (trastorno)Francia
-
Universitaire Ziekenhuizen KU LeuvenVlaams Instituut voor Biotechnologie (VIB)Terminado
-
McMaster UniversitySocial Sciences and Humanities Research Council of CanadaTerminado
-
University Hospital, BordeauxAún no reclutandoNutrición parenteral | Insuficiencia Intestinal Crónica | Productos Avanzados de GlicaciónFrancia
-
Dr Azita HekmatdoostTerminadoSíndrome metabólicoIrán (República Islámica de
-
Universitair Ziekenhuis BrusselUniversity Ghent; Universiteit Antwerpen; Artevelde University of Applied Sciences y otros colaboradoresReclutamiento
-
Kanuni Sultan Suleyman Training and Research HospitalTerminado
-
Icahn School of Medicine at Mount SinaiNational Institute on Aging (NIA)Terminado
-
Brigham and Women's HospitalTerminadoSíndrome del anciano frágil | Fragilidad | Envejecimiento | Síndrome de FragilidadEstados Unidos
-
University of BolognaEuropean CommissionTerminadoEnvejecimientoItalia, Francia, Países Bajos, Polonia, Reino Unido