- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt
- Faculty of physical therapy
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Control group
Effect of conventional therapy on control group |
Stretching of neck muscles and manual therapy and strengthening exercises |
|
Experimentální: 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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Joint position error
Časové okno: 6 weeks
|
Deviation from normal joint position is calculated |
6 weeks
|
|
Patient specific functional scale
Časové okno: 6 weeks
|
Measures function of cervical radiculopathy patient |
6 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P.T.REC/012/006393
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