- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07683676
Kinetic Control Training Versus Core Stability Exercises on Proprioception and Spatiotemporal Gait Parameters in Chronic Non-specific Low Back Pain (CNSLBP)
1 de julio de 2026 actualizado por: Ola Adel Abd Elrazik Ibrahem, Cairo University
This study will be conducted to comapre between kinetic control training versus core stability exercises on proprioception and spatiotemporal gait parameters in chronic non-specific low back pain.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Chronic nonspecific low back pain (CNSLBP) represents a significant public health problem and an economic burden to employers.
It has become one of the most common problems in industrialized societies; it can affect 80% of people and has become the most common cause of functional limitation in individuals younger than 35 years.
Neuromuscular impairments and deficits are a primary contributor to the inception and chronicity of Low back pain with the psychological and social competes.
Specific-oriented retraining has a major effect in modulating biopsychosocial competes severity and peculiarity and crucial for controlling chronic Low back pain.
Interventions targeting neuromuscular impairments of the movement system are the most promising movement control concepts in these Low back pain treatment approaches.Kinetic Control Training (KCT), which focuses on movement control and muscle coordination, has emerged as a potential intervention for addressing the underlying motor control deficits associated with CNSLBP.
Exercises in managing CNSLBP.
For instance, a randomized controlled trial demonstrated that core stability training significantly improved back muscle strength and reduced pain intensity in young adults with chronic non-specific low back pain.
To the best of authors' knowledge, the effect of kinetic control versus core stability training on the spatiotemporal parameters of the gait has not been investigated yet.
So this study will be conducted to investigate this point.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
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.
Estudio Contacto
- Nombre: ola Adel, phd
- Número de teléfono: 01207003453
- Correo electrónico: adelola191@gmail.com
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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Subjects from both sexes diagnosed with chronic non-specific low back pain with uncontrolled movement related to kinetic control concept
- aging range from 18-45 years
- Pain provoked by movement.
- Pain for at least 3 months
- Pain with sufficient intensity (equal to or greater than 4 points on VAS).
Exclusion Criteria:
- History of previous spinal surgery.
- Patients with lumbar spine diseases (for example, disc prolapse or spondylolisthesis).
- Patients with abnormal neurological signs in lower extremities, radicular pain in the lower limb, hip arthrosis, congenital musculoskeletal deformity, female patients with pelvic lesions, and pregnant females.
- Red flag signs include unwanted weight loss, less than three months of symptom persistence, malignancies of the spine, spinal instability due to structural cause, for example: ligamentous sprain or spondylolisthesis.
- Gynaecological problems in females that may cause low back pain include coccydynia and hysterotomy
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: Kinetic control group
Twenty patients will receive kinetic control training with conventional physical therapy three times a week for 8 weeks
|
Each patient in the group will be received kinetic control retraining with conventional physical therapy.
For each movement direction, specific control tests will be conducted.
The direction and site of the uncontrolled movement will be evaluated using special tests in accordance with the pain history of the patient.
conventional physical therapy includes Trans-cutaneous electric Nerve Stimulation (TENS), Heat by hot packs
|
|
Experimental: Core stability exercises group
Twenty patients will receive core stability exercises with conventional physical therapy three times a week for 8 weeks
|
conventional physical therapy includes Trans-cutaneous electric Nerve Stimulation (TENS), Heat by hot packs
Core stability exercises include curl up (head and shoulders lifting), bridging exercise with leg elevation, and quadruped with arm and leg lift will be performed with maintaining the lumbar spine neutral.
each patient in that group will be received core stability exercises with conventional physical therapy,
|
|
Comparador activo: Conventional physical therapy exercise
twenty patients will receive conventional physical therapy three times a week for 8 weeks
|
conventional physical therapy includes Trans-cutaneous electric Nerve Stimulation (TENS), Heat by hot packs
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
lumber repositioning error (lumbar proprioception)
Periodo de tiempo: up to 8 weeks
|
The iPhone® application will be used to assess lumbar repositioning error.
It will be placed vertically, halfway between the anterior superior and PSIS, just above the iliac crest, and fastened with a belt.
The initial location and the inclination of the inclinometer were both fixed at 0°.
There was a 0 to 30° range of motion (ROM).
The assessor gently guided the individual to a 30° flexion and instructed them to hold this posture for ten seconds.
After then, the participant actively went back to their starting location and subsequently did it three times.
|
up to 8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
pain intensity
Periodo de tiempo: up to 8 weeks
|
visual analogue scale will be used to assess pain intensity.t
consists of a 100-mm line with descriptive anchors representing extremes at each end, such as "no pain" and "worst pain imaginable.
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up to 8 weeks
|
|
gait speed
Periodo de tiempo: up to eight weeks
|
Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
normal, healthy gait speed for adults is generally between 1.0 m/s to 1.5 m/s.
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up to eight weeks
|
|
cadence
Periodo de tiempo: up to eight weeks
|
Cadence in gait is the rate at which steps are taken during locomotion, measured as steps per minute.Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
A healthy adult's normal walking cadence typically ranges between 100 to 120 steps per minute.
|
up to eight weeks
|
|
stride and step time
Periodo de tiempo: up to eight weeks
|
Stride time is the total time taken to complete one full gait cycle.
Step time is the time it takes to complete a single step.Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
Normal walking gait for a healthy adult at a comfortable pace typically features a stride time of about 1.15 seconds and a step time of about 0.5 to 0.6 seconds
|
up to eight weeks
|
|
stride and step length
Periodo de tiempo: up to eight weeks
|
Step length is the distance between the placement of one foot and the next placement of the opposite foot.
Stride length, conversely, covers the distance of two consecutive steps.
Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
A normal walking step length 58 to 76 cm.
A stride length averaging 52 to 60 inches.
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up to eight weeks
|
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COG vertical displacement
Periodo de tiempo: up to eight weeks
|
Vertical displacement of the Center of Gravity (CoG) typically refers to the rhythmic, up-and-down movement of the body's mass center during the human gait cycle.
In a normal walking step, this vertical movement ranges to about 5 cm, helping conserve overall energy and maintain smooth motion.Using Kinovea (an open-source software) (version 0.9.5), a freeware motion analysis software will be used to retrieve all of the videos from the Sony Video camera.
|
up to eight weeks
|
|
life disability
Periodo de tiempo: up to eight weeks
|
The WHOQOL-BREF will be used to assess life disability.
it is a 26-item survey evaluating Quality of Life (QoL) across four domains: Physical, Psychological, Social Relationships, and Environment.
Higher scores in each domain indicate a better perception of QoL
|
up to eight weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
10 de julio de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2026
Publicado por primera vez (Actual)
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P.T.REC/012/006359
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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