- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07679373
Effects of Clinical Based Versus Synchronized Telerehabilitation on Pain, Exercise Adherence, and Functional Disability Among Patients With Grade-II Cervical Spondylosis.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cervical spondylosis is a common degenerative condition of the cervical spine characterized by disc degeneration, osteophyte formation, and reduced cervical mobility, leading to neck pain and functional limitations. Grade-II cervical spondylosis represents a stage where patients are symptomatic but remain suitable for conservative management. Physiotherapy, particularly exercise-based rehabilitation, is widely used to improve pain, mobility, and functional capacity through strengthening, stretching, and neuromuscular re-education.
Clinical-based rehabilitation provides in-person physiotherapy with direct supervision, manual guidance, and real-time correction of exercises. However, access to such care is often limited due to barriers such as travel distance, cost, and time constraints. Synchronized telerehabilitation, delivered through real-time video conferencing, offers a potential alternative by enabling remote supervision, feedback, and patient engagement while maintaining continuity of care.
This randomized controlled trial aims to compare the effectiveness of clinical-based rehabilitation and synchronized telerehabilitation in patients with Grade-II cervical spondylosis. A total of 52 participants will be randomly assigned to two parallel groups. Both groups will receive a standardized 6-week rehabilitation program consisting of cervical range-of-motion exercises, deep cervical muscle strengthening, isometric exercises, stretching of the upper trapezius and levator scapulae, and Mulligan self-mobilization techniques (SNAGs). The clinical group will attend in-person sessions, while the telerehabilitation group will receive real-time supervised sessions via video conferencing.
Outcome measures include pain intensity assessed by the Numeric Pain Rating Scale (NPRS), functional disability measured by the Neck Disability Index (NDI), and exercise adherence evaluated using the Exercise Adherence Rating Scale (EARS), assessed at baseline and post-intervention.This study aims to determine whether synchronized telerehabilitation is comparable to clinical-based rehabilitation and may provide an accessible, cost-effective alternative for delivering physiotherapy care
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shoaib Waqas
- Número de teléfono: +923024552109
- Correo electrónico: shoaibwaqas@gmail.com
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- University of biological and applied sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Middle age adults (45-64) years
- Both gender ( male and female )
- Clinical daignosis of cervical spondylosis grade 2
- Mild to moderate pain on NPRS
- Sub acute stage ( 2-6 weeks) of grade 2 cervical spondylosis
- Able to follow instructions and give informed consent (cognitively able) Neurologically stable
Exclusion Criteria:
- Prior cervical spine surgery within the last 1 months or cervical instability.
- Inflammtory or systemic rheumatologic disease affecting the cervical spine (e.g., active rheumatoid arthritis ) or infection, tumor, fracture.
- Severe cardiopulmonary or other medical comorbidity that contraindicates exercise (unstable angina, uncontriolled hypertension, recent MI)
- Severe hearing or visual impairment
- No smoking and daibetic history
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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Experimental: Group A: Clinical Based Rehabilitation
Participants in Group A will receive clinical-based rehabilitation through in-person physiotherapy sessions in an outpatient setting.
Treatment will be delivered three times per week for 6 weeks, with each session lasting approximately 30-40 minutes.
All interventions will be provided under the direct supervision of a qualified physiotherapist, ensuring proper monitoring, guidance, and correction of patient performance during therapy sessions.
Participants will also receive standardized instructions for home-based continuation of care on non-supervised days to support consistency of rehabilitation.
The focus of this arm is to evaluate the effectiveness of traditional face-to-face physiotherapy care in improving pain, functional disability, and exercise-related outcomes in patients with Grade-II cervical spondylosis.
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The first intervention is clinical-based rehabilitation, delivered through in-person physiotherapy sessions in an outpatient clinical setting.
Participants will receive supervised treatment three times per week for 6 weeks, with each session lasting approximately 30-40 minutes.
All sessions will be conducted by a qualified physiotherapist who will provide direct monitoring, guidance, and correction to ensure proper execution of therapy.
This conventional rehabilitation approach emphasizes face-to-face interaction, allowing individualized attention and real-time clinical decision-making.
Participants will also be advised to continue prescribed home-based activities on non-session days to maintain consistency and support recovery outcomes.
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Comparador activo: Group B: Synchronized Telerehabilitation
Participants in Group B will receive synchronized telerehabilitation delivered through real-time video conferencing.
Sessions will be conducted three times per week for 6 weeks, with each session lasting approximately 30-40 minutes.
Rehabilitation will be supervised live by a qualified physiotherapist who will provide instruction, monitoring, and feedback during each session to ensure correct performance and safety.
This remote delivery model will replicate the structure of clinical-based rehabilitation while eliminating the need for in-person visits.
Participants will also be given standardized guidance for continuing home-based activities on non-session days.
This arm aims to evaluate the effectiveness of synchronized telehealth-based physiotherapy in improving pain, functional disability, and exercise adherence in patients with Grade-II cervical spondylosis.
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The second intervention is synchronized telerehabilitation, delivered through real-time video conferencing sessions.
Participants will receive supervised physiotherapy remotely three times per week for 6 weeks, with each session lasting approximately 30-40 minutes.
A qualified physiotherapist will provide live instruction, monitoring, and feedback to ensure correct performance and safety during exercises.
This approach replicates the structure of clinical-based rehabilitation while eliminating the need for in-person visits.
Participants will also be given standardized home-based activity instructions for non-session days to maintain continuity of care.
The intervention aims to evaluate the effectiveness of remote, technology-based rehabilitation in improving clinical outcomes in patients with Grade-II cervical spondylosis.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain Intensity
Periodo de tiempo: Measured at baseline (pre-intervention) and after 6 weeks (post-intervention completion).
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Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will rate their average neck pain over the past 24 hours.
The NPRS is a valid and reliable tool widely used in musculoskeletal conditions, including cervical spondylosis, to measure changes in pain severity.
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Measured at baseline (pre-intervention) and after 6 weeks (post-intervention completion).
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Functional Disability
Periodo de tiempo: Measured at baseline (pre-intervention) and at 6 weeks post-intervention completion.
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Functional disability will be assessed using the Neck Disability Index (NDI), a validated questionnaire designed to measure the impact of neck pain on daily activities.
It includes domains such as pain intensity, personal care, lifting, reading, work, concentration, sleep, and recreation.
Each item is scored, with higher total scores indicating greater disability.
The NDI is widely used in cervical spine disorders due to its strong reliability, validity, and sensitivity to clinical change.
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Measured at baseline (pre-intervention) and at 6 weeks post-intervention completion.
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Exercise Adherence
Periodo de tiempo: Measured at baseline and at 6 weeks post-intervention completion.
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Exercise adherence will be assessed using the Exercise Adherence Rating Scale (EARS), a validated self-reported questionnaire designed to measure the extent to which patients comply with prescribed home exercise programs.
It evaluates behaviors such as frequency of exercise performance, consistency in following instructions, and patient commitment to rehabilitation.
The scale provides insight into adherence patterns that directly influence treatment effectiveness in musculoskeletal conditions.
Higher scores indicate better adherence to the prescribed exercise regimen.
The EARS is widely used in rehabilitation research due to its good reliability and internal consistency.
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Measured at baseline and at 6 weeks post-intervention completion.
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Colaboradores e Investigadores
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Otros números de identificación del estudio
- UBAS/ERB/26/04/034
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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