Effect of Kinetic Control Retraining on Neck Proprioception and Functional Outcome in Patients With Cervical Radiculopathy

NCT06803134 | Recruiting

• 1 other identifier: P.T.REC/012/004919
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of kinetic control retraining on neck proprioception and functional outcome in patients with cervical radiculopathy.

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (2)

• Evaluation of cervical proprioception using the cervical range of motion (CROM) device

  Cervical proprioception will be assessed using the CROM device. Subjects will sit upright in a neutral head position with their trunk and shoulders secured by Velcro straps and will be blindfolded. The CROM unit will be calibrated to zero and secured on the head, with the magnetic yoke positioned on the shoulder. Two tests will be conducted: the Neutral Head Repositioning Test (NHR), where subjects rotate their heads left and return to neutral with accuracy measured in degrees, and the Target Head Repositioning Test (THR), where cervical range of motion will be tested, and subjects will reproduce a memorized target position. Each test will be repeated three times, with average angular displacement error calculated.

  8 weeks

• Assessment of deep neck flexors (DNFs) strength by craniocervical flexion test (CCFT) using pressure biofeedback unit (PBU)

  The craniocervical flexion test, a valid and reliable tool for assessing deep neck flexor (DNF) muscle performance, involves positioning the participant in a crook-lying position with a pressure biofeedback unit (PBU) placed under the head. The participant holds the PBU's dial to guide the test, which progresses through five stages based on the pressure exerted at a neutral head position (22, 24, 26, 28, and 30 mmHg). Starting at 20 mmHg, participants perform a slow head nod to incrementally increase the pressure by 2 mmHg, holding each increment for three seconds. Baseline performance is the maximum pressure held correctly for three seconds without substitution, monitored by the tester through palpation of superficial flexors.

  8 weeks

Secondary Outcomes (2)

• Evaluation of neck pain intensity using the Visual Analogue Scale (VAS)

  8 weeks

• Evaluation of neck-related functional performance using the Arabic version of Neck Disability Index (NDI)

  8 weeks

Study Arms (2)

Selected physical therapy program + Kinetic control retraining

EXPERIMENTAL

Participants in this group will be treated by kinetic control retraining for 30 minutes in addition to selected physical therapy program for 30 minutes, 3 sessions per week (day after day), for 8 weeks.

Other: Selected physical therapy program; Other: Kinetic control retraining

Selected physical therapy program

ACTIVE COMPARATOR

Participants in this group will be treated by the same selected physical therapy program for 30 minutes, 3 sessions per week (day after day), for 8 weeks.

Other: Selected physical therapy program

Interventions

Selected physical therapy program OTHER

Both groups will receive a selected physical therapy program in the form of trans-cutaneous electrical nerve stimulation (TENS), moist hot pack, posture education, and strengthening exercises for deep neck flexors, for 30 minutes, 3 sessions per week, for 8 weeks.

Selected physical therapy program; Selected physical therapy program + Kinetic control retraining

Kinetic control retraining OTHER

Each patient in the experimental group will receive kinetic control retraining for 30 minutes, 3 sessions per week, for 8 weeks. Each session is based on the progression on the motor control rating scale (MCRS) related to kinetic control management frame. 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. The tests will be chosen according to the patient"s symptoms; screening of all patients will be done through at least three tests in each direction according to the patient"s symptoms.

Selected physical therapy program + Kinetic control retraining

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Forty Four patients suffering from chronic cervical unilateral radiculopathy (symptomatic duration) (3 months to 1year).
• Their age ranges 40-55 years, from both sexes.
• Body mass index (BMI) of less than 30 Kg/m2
• Cervical spondylosis (at the levels of C5-C6/C6-C7 confirmed by cervical MRI)..

You may not qualify if:

• Cervical myelopathy with evidence of pyramidal, posterior column, and or spinothalamic tract lesions.
• Patients with decreased range of motion of cervical spine secondary to congenital anomalies, musculature contracture, or bony block.
• Previous cervical or shoulder surgery or trauma.
• Cervical instability caused by structural problem (e.g. ligament tear or spondylolithesis.
• Psychological problems interfering with the patient understanding of the orders, or patients who did not have direction preference.
• Vertebro-basilar artery insufficiency, diabetic neuropathy.
• Comorbidities that impact physical activity (e.g., cerebrovascular accidents, severe heart disease). - Double crush syndrome and thoracic outlet syndrome.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Horus University

Damietta, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Nahed Ahmed Salem, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Ebtesam Wafik Osman Shehab El-Din, M.Sc

CONTACT

+20 10 01447604; ebtsShehab96@gmail.com

Nagwa Ibrahim Rehab, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 15, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

EG (1)