- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07585084
Neural Mobilisation Effect on Calf Muscle
12 de mayo de 2026 actualizado por: NITHIYAH MARUTHEY, INTI International University
The Effect of Neural Mobilization on Calf Muscle Length and Strength in Ballet Dancers: a Randomized Controlled Trial
The purpose of this study was to investigate Neural mobilisation effects on calf muscles length and strength is crucial to optimize ballet performance and prevent injuries.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A randomized controlled trial is conducted with a total of 54 non-professional ballet dancers recruited from ballet studios across the Klang Valley following inclusion and exclusion criteria.
Baseline measurement of calf muscle performance was conducted before randomization using knee-to-wall (KtW) test, handheld dynamometer (HHD) and Y-balance (YBT).
Participants were allocated to experimental (NM and self-stretching) or control (self stretching) .
Tipo de estudio
Intervencionista
Inscripción (Actual)
54
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Negeri Sembilan
-
Seremban, Negeri Sembilan, Malasia, 71800
- INTI International University
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Classical ballet trained female or male .
- Subjects who are trained in classical ballet syllabus such as Royal Academy of Dance (RAD) Syllabus, The Classical Ballet Syllabus by Commonwealth Society of Teachers of Dancing (CSTD), Vaganova Syllabus and more.
- Aged 13-23 years old
- Dancers who took class/practice ballet for at least 3 times per week
- Participated in ballet competition in recent 6 months
Exclusion Criteria:
- Professional full time ballet dancers
- Non-ballet dancers
- Self-reported lower extremity injuries in the past 6 months prior to date of data collection
- Subjects with existing musculoskeletal injuries might affect calf muscle performance
- Involvement in other sports or physical training
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Neural mobilisation group
neural mobilisation of tibial nerve and gastrocnemius stretching
|
the neural mobilisation was done with placement of participant's leg in hip flexion, knee extension, ankle dorsiflexion and eversion to load the nerve.
Then leg is placed back to neutral position, with ankle naturally plantarflexed to unload the nerve.
NM of tibial nerve was done in a total of 10 seconds each repetition, with 5 seconds each for loading and unloading of nerve.
Then 12 repetition was done in one set, which amount to a total of 120seconds or 2 minute per set.
A total of 3 sets was done on each leg, with a 1-minute resting interval after each set.
NM was administered to participants in experimental group before their ballet class for 3 times a week lasting for 4 weeks.
Otros nombres:
Participants was instructed to perform the classic wall stretch for gastrocnemius as self-stretching for a duration of 30 seconds each leg.
It was done facing the wall and one leg had knee flexed in front while the other leg had knee extended behind.
A 30 second hold was maintained at maximum stretched position by leaning forward while both soles of feet remain contact on the ground.
Self-stretch was performed throughout the 4-week study duration before every ballet training or class.
Otros nombres:
|
|
Comparador activo: Gastrocnemius stretching group
Participants was instructed to perform the classic wall stretch for gastrocnemius as self-stretching for a duration of 30 seconds each leg.
It was done facing the wall and one leg had knee flexed in front while the other leg had knee extended behind.
A 30 second hold was maintained at maximum tretched position by leaning forward while both soles of feet remain contact on the round.
Self-stretch was performed throughout the 4-week study duration before every ballet training or class.
|
Participants was instructed to perform the classic wall stretch for gastrocnemius as self-stretching for a duration of 30 seconds each leg.
It was done facing the wall and one leg had knee flexed in front while the other leg had knee extended behind.
A 30 second hold was maintained at maximum stretched position by leaning forward while both soles of feet remain contact on the ground.
Self-stretch was performed throughout the 4-week study duration before every ballet training or class.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
knee to wall test
Periodo de tiempo: From enrollment to the end of treatment at 4 weeks
|
The participants placed the testing foot onto the measuring tape with foot perpendicular to the wall while lunging or bending the knee to touch the wall.
Then participants slide their foot further away from the wall as much as ossible while maintaining contact of knee to the wall as well as heel of foot on the floor.
The calf muscle flexibility is evaluated with the measurement of distance from the great toe to the wall will be the maximum possible ankle dorsiflexion for the individual.
|
From enrollment to the end of treatment at 4 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Calf muscle strength
Periodo de tiempo: From enrollment to the end of treatment at 4 weeks
|
Calf muscle strength was measured using handheld dynamometer (HHD).The device was placed at the plantar aspect of metatarsophalangeal joint height and the body of HHD should be maintained perpendicular to the plane of ankle plantarflexion movement.
Isometric contraction of ankle plantarflexor was done in maximum possible force for 5 seconds.
Participant performed one trial to familiarize with the test, followed by 3 repetitions alternated on each leg with 1-minute resting interval.
|
From enrollment to the end of treatment at 4 weeks
|
|
Dynamic balance using Modified Star Excursion Balance Test (mSEBT)
Periodo de tiempo: From enrollment to the end of treatment at 4 weeks
|
Participants maintained their hands on the hip and reached tip of hallux to the maximal distance.
The reaching foot were to avoid touching the ground and the heel of standing foot should remain on the ground.
One trial on each direction was performed to familiarize with the test, followed by three trials with 1 minute resting interval.
Normalize reach distance to lower limb length and normalized composite score were calculated to ultimately evaluate dynamic balance of an individual.
|
From enrollment to the end of treatment at 4 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: NITHIYAH MARUTHEY, INTI International University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Cho SY, Myong Y, Park S, Cho M, Kim S. A portable articulated dynamometer for ankle dorsiflexion and plantar flexion strength measurement: a design, validation, and user experience study. Sci Rep. 2023 Dec 14;13(1):22221. doi: 10.1038/s41598-023-49263-2.
- Avila-Carvalho L, Conceicao F, Escobar-Alvarez JA, Gondra B, Leite I, Rama L. The Effect of 16 Weeks of Lower-Limb Strength Training in Jumping Performance of Ballet Dancers. Front Physiol. 2022 Jan 12;12:774327. doi: 10.3389/fphys.2021.774327. eCollection 2021.
- Alimoradi M, Sahebozamani M, Hosseini E, Konrad A, Noorian S. The Effect on Flexibility and a Variety of Performance Tests of the Addition of 4 Weeks of Soleus Stretching to a Regular Dynamic Stretching Routine in Amateur Female Soccer Players. Sports (Basel). 2023 Jul 19;11(7):138. doi: 10.3390/sports11070138.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
20 de agosto de 2024
Finalización primaria (Actual)
15 de enero de 2026
Finalización del estudio (Actual)
15 de enero de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- INTI-IU/FHLS-RC/BPTHI/1NY12024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
Upon careful consideration it will be decided to protect participants privacy
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .