NCT07326202

Brief Summary

This study will be conducted to:

  • Investigate the relationship between neck pain severity and bilateral gait symmetry in patients with cervical radiculopathy.
  • Investigate the relationship between deep neck flexors strength and gait symmetry in patients with cervical radiculopathy.
  • Investigate the relationship between upper limb muscles strength and bilateral gait symmetry in patients with cervical radiculopathy.
  • Determine factors predicting bilateral gait asymmetry in patients with cervical radiculopathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 24, 2025

Last Update Submit

December 24, 2025

Conditions

Outcome Measures

Primary Outcomes (11)

  • Pain Assessment

    The level of upper limb and neck pain will be captured separately with the Numeric Pain Rating Scale (NPRS). Using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable), participants will be asked to answer the following question: "On a scale of 0 to 10, where 0 = no pain and 10 = worst pain, evaluate the intensity of your neck pain at this moment ". The same question will be asked for the upper limb. The NPRS is frequently used in clinical studies in association with the neck disability index.

    1 day

  • Assessment of function and disability

    Arabic version of Neck Disability Index (NDI) will be used to assess disability and function limitation caused by neck pain. It has demonstrated excellent internal consistency (Cronbach's alpha between 0.88 and 0.94) and test-retest reliability (ICC = 0.90-0.98). It includes 10 items, each scored on a 0-5 scale, about: personal care, lifting, reading, concentration, work, driving, and sleeping. The total maximum score is 50 and categorize disability from none to complete , The Arabic version of NDI is a strong valid method for assessing self-rated disability in patients with neck pain with excellent "test-retest" reliability. Based on the total score (out of 50), disability will be categorized as: 0-4 = no disability, 5-14 = mild, 15-24 = moderate, 25-34 = severe, \>34 = complete disability

    1 day

  • strength of deep neck flexors

    Pressure Biofeedback Unit (PBU) will be used to assess deep neck flexor strength. From a supine position and both knees bent in flexion and arms relaxed at the sides. The PBU cuff will be placed under the suboccipital region of his neck and then inflated to a baseline pressure of 20 mmHg. Patients will be instructed to perform a gentle chin in motion without lifting their heads off the surface or activating superficial muscles. The patient will then be guided to increase the pressure in 2 mmHg stages to a maximum of 30 mmHg, and to hold each stage for 10 seconds taking no rest intervals between his attempts. The maximum pressure which he achieves and holds correctly without compensatory strategies will be recorded. 3 trials will be conducted.

    1 day

  • Upper limb strength assessment

    Upper limb strength will be measured using a hand-held dynamometer. Participants will be seated in upright posture, with their shoulders adducted and neutrally rotated, and their elbows will be flexed at 90 degrees, their forearms will be placed in a neutral position, and their wrists extended between 0-30 degrees, testing protocol. Each participant will be instructed to grip the dynamometer with his maximum effort for about 3-5 seconds. The participant will receive consistent verbal encouragement from the assessor to ensure maximal voluntary contraction is achieved. Each participant will perform 3 trials on their affected side, with a one-minute rest between his attempts to avoid muscle fatigue.

    1 day

  • Cadence

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Cadence is the number of steps taken per minute (steps/minutes).

    1 day

  • Gait Velocity

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Gait Velocity is the average walking speed, calculated as Gait Distance divided by Gait Time (centimeter/second).

    1 day

  • Symmetry Index (SI)

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Symmetry Index (SI) is a calculated percentage representing the degree of asymmetry between the right and left sides for any given gait parameter (%). Formula used: SI = \[(Right - Left) / 0.5 \* (Right + Left)\] \* 100.

    1 day

  • Step Time symmetry index

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Step time is the percentage of asymmetry between the right step time and the left step time (%).

    1 day

  • Step Length symmetry index

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Step Length is a percentage of asymmetry between the right step length and the left step length (%).

    1 day

  • Single Support Time symmetry index

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Single Support Time is the percentage of asymmetry between the average right single support time and the average left single support time (%).

    1 day

  • Double Support Time symmetry index

    The Tekscan Strideway™ system will be used to objectively assess spatiotemporal gait parameters for all participants with cervical radiculopathy. Double Support Time is the percentage of asymmetry between the average right total double support time and the average left total double support time (%).

    1 day

Study Arms (1)

Cervical radiculopathy group

Sixty-one patients with cervical radiculopathy of both sexes will participate in this study. Patients will be diagnosed as having cervical radiculopathy by neurologist based on a careful clinical examination and will be confirmed by investigations as magnetic resonance imaging (MRI).

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sixty one patients with cervical radiculopathy of both sexes will participate in this study. Patients will be diagnosed as having cervical radiculopathy by neurologist based on a careful clinical examination and will be confirmed by investigations as magnetic resonance imaging (MRI). Patients will be selected from the Outpatient Clinic of Faculty of Physical Therapy, and the British University in Egypt

You may qualify if:

  • Patients with unilateral cervical radiculopathy at level of C5-C6 and C6-C7 confirmed by MRI.
  • Patient's age will be ranged from 40 to 50 years.
  • Patients with chronic symptoms \> 3 months.
  • Patients with decreased strength in cervical or upper limb muscles.
  • Ability to walk independently without assistive devices.
  • Patients with normal body mass index (BMI) (\< 30kg/m²) .

You may not qualify if:

  • Bilateral cervical radiculopathy.
  • History of cervical spine surgery or instability.
  • Diagnosed with myelopathy, canal stenosis, or severe disc protrusion.
  • History of vestibular dysfunction, stroke, or severe cognitive impairment.
  • Any Lower limb dysfunction affecting walking.
  • Peripheral neuropathy or uncontrolled diabetes.
  • Psychiatric diseases
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hossam Abdelwahab mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Ebtesam Fahmy, Professor

    Cairo University

    STUDY DIRECTOR
  • Nagwa Rehab, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hossam Mohamed, Master

CONTACT

Mohamed Helayel, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

December 30, 2025

Primary Completion

March 25, 2026

Study Completion

March 30, 2026

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations