- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07565688
Forward Head Posture Correction on Cerebral Oxygenation During Dual-task in Symptomatic Subjects (FHP)
Effects of Forward Head Posture Correction on Prefrontal Cerebral Oxygenation During Cognitive-Motor Interference in Symptomatic Subjects With Forward Head Posture: A Randomized Controlled Trial
This study aims to investigate the effects of forward head posture correction on neck pain, brain activity, and cognitive-motor performance. Forward head posture is a common postural problem, especially among young adults who spend long hours using smartphones and computers. It is frequently associated with neck pain, reduced mobility, and functional limitations. Emerging evidence also suggests that this postural deviation may influence brain function and increase the mental effort required during tasks that involve both thinking and movement.
Participants with forward head posture and neck pain will be recruited and randomly assigned to one of three groups: an intervention group using a cervical traction device (Denneroll), a sham group using a towel roll, or a control group receiving no intervention. The intervention will be performed at home over a six-week period, with sessions conducted five times per week. The duration of each session will gradually increase based on participant tolerance to ensure safety and comfort.
All participants will undergo assessments at baseline and after the intervention period. Pain intensity will be measured using a standardized pain scale. Brain activity will be assessed using a non-invasive technique called functional near-infrared spectroscopy (fNIRS), which measures changes in oxygen levels in the brain. Participants will also perform balance tasks under single-task and dual-task conditions, where they will be asked to maintain balance while performing simple cognitive tasks. In addition, cognitive function will be evaluated using standardized tests of attention, memory, and overall cognitive performance.
This study will help determine whether correcting forward head posture can reduce pain and improve brain and cognitive function. The findings may provide valuable insights into the relationship between posture, pain, and brain activity, and may contribute to the development of more effective and comprehensive rehabilitation approaches for individuals with forward head posture.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Forward head posture (FHP) is a common postural deviation associated with neck pain, impaired sensorimotor control, and functional limitations. In addition to musculoskeletal effects, emerging evidence suggests that FHP may influence cortical activity, particularly within prefrontal regions involved in attention and cognitive-motor integration. Individuals with FHP have demonstrated increased cognitive-motor interference during dual-task performance, indicating greater reliance on cortical resources and reduced motor automaticity. However, it remains unclear whether correcting FHP can reduce pain and modify these neurophysiological responses.
This study aims to investigate the effects of forward head posture correction on pain intensity as a primary outcome, alongside task-evoked cerebral oxygenation and cognitive-motor interference. A prospective, single-blinded, randomized controlled trial design with three parallel groups will be used. Participants with symptomatic FHP will be randomly allocated to an intervention group receiving Denneroll cervical traction, a sham group receiving a non-therapeutic towel roll intervention, or a control group receiving no intervention.
The intervention will be conducted over six weeks, with participants in the intervention and sham groups performing home-based sessions with gradual progression in duration to ensure safety and tolerance. All participants will undergo assessments at baseline and post-intervention.
Pain intensity will be evaluated using the Visual Analog Scale (VAS). Neurophysiological outcomes will be assessed using functional near-infrared spectroscopy (fNIRS) to measure changes in oxygenated and deoxygenated hemoglobin in the prefrontal cortex during rest, single-task, and dual-task conditions. Cognitive-motor interference will be examined using dual-task paradigms that combine balance tasks with cognitive demands. Cognitive function and balance performance will also be evaluated using standardized assessments.
The procedures used in this study are non-invasive and associated with minimal risk. The fNIRS device does not emit radiation, and the intervention may cause only mild and temporary discomfort, which will be minimized through gradual progression and monitoring. Participants will be informed of their right to withdraw at any time without consequences.
By integrating clinical, cognitive, and neurophysiological outcomes, this study aims to provide a comprehensive understanding of the effects of forward head posture correction. The findings may contribute to the development of more effective, mechanism-based rehabilitation strategies targeting both pain and brain function in individuals with forward head posture.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Reime Jamal Shehadeh Shalash, PhD-Teaching assistant
- Número de teléfono: +971 52-5568334
- Correo electrónico: reemjamal25@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Alham Al-Sharman, PhD-Associate Prof
- Número de teléfono: 06-5057516
- Correo electrónico: aal-sharman@sharjah.ac.ae
Ubicaciones de estudio
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Sharjah city, Emiratos Árabes Unidos, 27272
- University of Sharjah
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Contacto:
- Alham Al-sharman
- Número de teléfono: 06-5057516
- Correo electrónico: aal-sharman@sharjah.ac.ae
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Young adults of both sexes aged 18-35 years
- Individuals with forward head posture (a craniovertebral angle (CVA) < 50°)
- Presence of neck pain with an intensity of ≥3 on the Visual Analog Scale (VAS)
- Ability to understand and follow basic English instructions
- No cognitive impairment (score >18 on the Montreal Cognitive Assessment (MoCA))
Exclusion Criteria:
- History of cervical spine surgery or significant cervical trauma
- Currently receiving physiotherapy or rehabilitation for cervical spine conditions
- Individuals on medications (diagnosed neurological disorders)
Plan de estudios
¿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 |
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Comparador activo: Denneroll group (DG)
The intervention group will receive Denneroll cervical traction
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Duration: 6 weeks Frequency: 5 sessions per week (total 30 sessions) Setting: Home-based Position: Supine Session duration: Starts at ~3 minutes, progressively increased to 15-20 minutes (as tolerated) - Intervention: DG: The denneroll will be given under the cervical spine (based on deviation level) TG: A towel roll will be given as an intervention CG: No intervention This protocol simultaneously examines cerebral oxygenation using functional near-infrared spectroscopy (fNIRS)(HbO and HbR) , during single- and dual-task balance conditions(cognitive load-motor balance), and pain intensity using the VAS, postural alignment (craniovertebral angle),and cognitive function (MoCA, SDMT, BVMT-R) before and after intervention. |
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Comparador falso: Towel group (TG)
The placebo group will receive a towel roll as an intervention
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Duration: 6 weeks Frequency: 5 sessions per week (total 30 sessions) Setting: Home-based Position: Supine Session duration: Starts at ~3 minutes, progressively increased to 15-20 minutes (as tolerated) - Intervention: DG: The denneroll will be given under the cervical spine (based on deviation level) TG: A towel roll will be given as an intervention CG: No intervention This protocol simultaneously examines cerebral oxygenation using functional near-infrared spectroscopy (fNIRS)(HbO and HbR) , during single- and dual-task balance conditions(cognitive load-motor balance), and pain intensity using the VAS, postural alignment (craniovertebral angle),and cognitive function (MoCA, SDMT, BVMT-R) before and after intervention. |
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Sin intervención: control group (CG)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The visual analog scale
Periodo de tiempo: Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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The Visual Analog Scale (VAS) is a validated measure of pain intensity, typically presented as a 10 cm (100 mm) horizontal line.
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
Higher scores represent greater pain intensity.
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Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Technobody Balance System (Balance performance)
Periodo de tiempo: Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Balance performance measurements will be evaluated using the Technobody Balance System under both single-task and dual-task conditions.
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Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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functional near-infrared spectroscopy
Periodo de tiempo: Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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cerebral oxygenation using functional near-infrared spectroscopy (fNIRS): Task-evoked cerebral: Changes in oxygenated (ΔHbO) and deoxygenated hemoglobin (ΔHbR) at rest, and during single-task and dual-task conditions will be calculated relative to pre-task baseline Cortical dual-task cost: The difference between dual-task and single-task ΔHbO will be used as an index of cognitive-motor interference. |
Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Symbol Digit Modalities Test
Periodo de tiempo: Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Symbol Digit Modalities Test (SDMT) is used to assess divided attention, visual scanning, tracking and motor speed.
The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of the sheet.
The participants will be asked to pair specific numbers with given geometric figures within 90 s using a reference key.
The participants should respond by voicing the digit associated with each symbol as quickly as possible.
SDMT-Incidental learning (IL) will be measured as well.
The participants will be asked to recall each geometric figure represented which number after 20 minutes.
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Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Brief Visuospatial Memory Test-Revised
Periodo de tiempo: Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Brief Visuospatial Memory Test-Revised (BVMT-R) is used to assess visuospatial learning and memory performance.
The BVMT-R consists of stimulus card (2 × 3 geometric figures).
The researcher will show the participant a stimulus array of six abstract geometric figures for 10 seconds, then the participant will be asked to draw the figures from memory in their correct shape and locations.
This procedure will be repeated for three learning trials.
The participants will be asked to recall each geometric figure after 20 minutes
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Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Montreal Cognitive Assessment
Periodo de tiempo: Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Montreal Cognitive Assessment (MoCA) is a simple 10 min paper and pencil test, with accepted test-retest reliability and moderate validity, that was developed to detect mild cognitive impairment.
The test assesses multiple cognitive domains including memory, language, executive functions, visuospatial skills, calculation, verbal abstraction, attention, concentration, and orientation to time and space.
The clinical cut-off score of 26 is recommended.The test and instructions are freely available on the MoCA official website at www.mocatest.org.
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Outcome measures will be collected at baseline (week 0) and after completion of the intervention (week 6).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alham Alsharman, Associate Prof., University of Sharjah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- REC-26-04-23-05-PG
Información sobre medicamentos y dispositivos, documentos del estudio
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