NCT07158281

Brief Summary

The aim of this study is to examine the impact of motor and cognitive dual-task conditions on gait variability and gait symmetry in individuals with NSNP, compared with healthy controls. This cross-sectional trial will recruit participants aged 18-60, including 21 patients with NSNP and 21 age-matched healthy controls. Gait parameters will be assessed using a wearable sensor system (BTS G-Walk). Primary outcomes are gait variability and gait symmetry under single-task, motor dual-task, and cognitive dual-task walking conditions.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 28, 2025

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Gait Variability

    Gait variability calculated using the coefficient of variation.Gait variability is the ratio of the mean to the standard deviation and is calculated as a percentage. The score ranges from 0 to 100. A higher score indicates greater variability and decreased gait control. formula. Measurement Tool: BTS G-Walk wearable sensor system.

    up to 3 months

  • Gait Symmetry

    Symmetry Index (SI) of spatiotemporal gait parameters between right and left limbs, calculated with the standard formula.Measurement Tool: BTS G-Walk wearable sensor system.Gait symmetry is calculated using a formula that compares the right and left extremities. "0" indicates complete symmetry, while "≥1" indicates asymmetry.

    up to 3 months

  • Pain Intensity

    Neck pain intensity measured using the Visual Analog Scale (VAS, 0-10).

    Assessed at baseline.

  • Neck Disability Index (NDI)

    Self-reported questionnaire assessing functional disability related to neck pain. Validated Turkish version will be used.he NDI is a 10-item questionnaire assessing neck pain-related disability in daily life (e.g., pain intensity, personal care, concentration, work, driving, sleeping).Each item is scored from 0 to 5 (0 = no disability, 5 = maximum disability). The total score ranges from 0 to 50.

    Assessed at baseline (only in NSNP group).

  • Bournemouth Neck Questionnaire (BNQ)

    elf-reported questionnaire evaluating pain severity, emotional distress, fear of movement, and coping strategies. Validated Turkish version will be used.The BNQ is a 7-item questionnaire evaluating the impact of neck pain on pain severity, activities of daily living, emotional well-being, anxiety/depression, fear of movement (kinesiophobia), and coping strategies. Scoring: Each item is scored on a 0-10 numeric rating scale (0 = no problem, 10 = maximum problem). The total score ranges from 0 to 70. Interpretation: Higher scores indicate greater disability and psychosocial impact of neck pain.

    Assessed at baseline (only in NSNP group).

Study Arms (2)

Nonspecific Neck Pain

Adults aged 18-60 with chronic nonspecific neck pain (≥3 months), scoring ≥10 on the Neck Disability Index, no neurological/systemic disease, no prior cervical surgery.

Healthy Control

Age- and sex-matched adults without neck pain or neurological/systemic disorders.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adults aged 18-60 years, including individuals with chronic nonspecific neck pain (NSNP) and age-matched healthy volunteers. Participants will be recruited from the students, staff, and first-degree relatives of Yüksek İhtisas University, Faculty of Health Sciences. The NSNP group will include participants with a history of neck pain lasting at least three months and a Neck Disability Index (NDI) score of ≥10. The control group will include individuals without neck pain or neurological, systemic, or musculoskeletal disorders.

You may qualify if:

  • for NSNP group:
  • Adults aged 18-60 years
  • History of nonspecific neck pain lasting at least 3 months
  • Neck Disability Index (NDI) score ≥10
  • Willingness to participate and provide informed consent
  • for the Healthy Control group
  • Adults aged 18-60 years
  • No history of neck pain or musculoskeletal/neurological/systemic disorders
  • Willingness to participate and provide informed consent

You may not qualify if:

  • Previous spinal surgery
  • History of traumatic cervical injury
  • Diagnosed cervical radiculopathy, spondylosis, spondylolisthesis, or disc herniation
  • Presence of any neurological or systemic disease
  • Musculoskeletal disorders affecting gait performance
  • Cognitive impairment or psychiatric conditions interfering with test participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Busra Kalkan Balak

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Elıf Sena Colak

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Aslı Isıkdemır

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Demet Cıhan

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gungor Beyza Ozvar Senoz

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investıgator

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

June 1, 2025

Primary Completion

October 15, 2025

Study Completion

November 1, 2025

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations