- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07936474
Effect of Proprioceptive Training on Cervical Sensorimotor Control and Functional Recovery in Patients With Cervical Radiculopathy (Proprioceptive)
Study purpose
The goal of this study is to investigate whether adding cervical proprioceptive training to conventional physiotherapy improves cervical sensorimotor control and functional recovery in patients with chronic cervical radiculopathy.
The study will include 58 participants, aged 35-50 years, with unilateral chronic cervical radiculopathy associated with lower cervical discogenic or spondylotic changes (C5-C6 and/or C6-C7), with symptoms lasting more than three months.
Main research questions
- Does cervical proprioceptive training, in addition to conventional physiotherapy, improve cervical joint position sense (measured by cervical joint position error) compared with conventional physiotherapy alone?
- Does adding cervical proprioceptive training lead to greater improvements in functional disability, pain intensity, functional ability, and cervical range of motion compared with conventional physiotherapy alone?
Comparison groups
Researchers will randomly allocate participants into two groups:
- Experimental group: Participants will receive conventional physiotherapy combined with a structured cervical proprioceptive training programme.
- Control group: Participants will receive conventional physiotherapy alone.
The researchers will compare the two groups to determine whether adding cervical proprioceptive training produces greater improvements in cervical sensorimotor control and functional outcomes.
What participation involves
Participants will be asked to:
- Complete baseline assessments, including the Neck Disability Index (NDI), Visual Analogue Scale (VAS), cervical joint position error (JPE), cervical range of motion (CROM), and Patient-Specific Functional Scale (PSFS).
- Attend their assigned physiotherapy programme three times per week for six weeks, with treatment sessions lasting approximately 60 minutes.
- Follow the treatment programme assigned to their group.
- Complete the same outcome assessments after the six-week intervention period to evaluate changes and compare the results between groups.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This study is a two-arm, parallel-group randomized clinical trial designed to investigate the effects of a structured cervical proprioceptive training program in individuals with chronic cervical radiculopathy.
Following baseline assessment, participants will be randomly allocated to either an experimental group receiving cervical proprioceptive training or a control group receiving conventional physiotherapy. The intervention period will last six weeks. Treatment sessions will be conducted three times per week, with each session lasting approximately 60 minutes.
The experimental group will receive a supervised cervical proprioceptive training program intended to address impaired cervical sensorimotor control. Training will focus on cervical joint-position awareness, accurate repositioning of the head, and controlled cervical movement. Exercises will be introduced at an appropriate level of difficulty and progressed according to the participant's performance, movement accuracy, tolerance, and ability to complete the tasks with adequate control. Training will be conducted under physiotherapist supervision.
The control group will receive a conventional physiotherapy program over the same six-week treatment period. Treatment will follow the conventional physiotherapy procedures specified in the study protocol and will be delivered according to the standardized intervention plan.
Participants will undergo the planned study assessments before and after the intervention period. The treatment period, session duration, and intervention procedures will be applied consistently according to the study protocol. Attendance and intervention implementation will be monitored throughout the study.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Giza Governorate
-
Giza, Giza Governorate, Египет
- Faculty of physical therapy
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients of both sexes, diagnosed as having unilateral cervical radiculopathy secondary to discogenic and spondylotic changes at the lower cervical spine (C5-C6 and C6-C7).
- Duration of illness more than "three" months.
- Aged between 35-50 years old.
- Body mass index (BMI) of less than 30 kg/m².
- 4-7/10 score according to VAS (Appendix I).
- Neck Disability Index (NDI) score ≥10/50.
- PSFS scoring of ≥ 5/10
Exclusion Criteria:
- Cervical myelopathy or cervical myelo-radiculopathy.
- Thoracic outlet syndrome.
- Carpal tunnel syndrome.
- Structural spinal instability such as spondylolisthesis.
- Vertebro-basilar artery insufficiency.
- Previous cervicothoracic spine surgery.
- Serious spinal pathology (e.g., tumors or infection).
- Vestibular or severe visual disorders.
- Associated other neurological diseases.
- Recent cervical physiotherapy within the last 2 months
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Control group
Effect of conventional therapy on control group |
Stretching of neck muscles and manual therapy and strengthening exercises |
|
Экспериментальный: Study group
Effect of proprioceptive training on stufy group |
Stretching of neck muscles and manual therapy and strengthening exercises Proprioceptive training using head mounted laser and target grids and tracking grids |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Joint position error
Временное ограничение: 6 weeks
|
Deviation from normal joint position is calculated |
6 weeks
|
|
Patient specific functional scale
Временное ограничение: 6 weeks
|
Measures function of cervical radiculopathy patient |
6 weeks
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- P.T.REC/012/006393
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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