Neck PainNCT07158281
Dual-Task Effects on Gait in Nonspecific Neck Pain
An observational study of Neck Pain and Gait, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Adults aged 18-60 years
- No history of neck pain or musculoskeletal/neurological/systemic disorders
- Willingness to participate and provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Dual-Tasking on Gait Variability and Symmetry in Individuals With Nonspecific Neck Pain
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.
Read the detailed description
Each participant will complete three walking conditions:
Single-task walking (walking at a self-selected pace), Motor dual-task walking (walking while carrying a tray with a glass of water), and Cognitive dual-task walking (walking while verbally reporting the number of letters in presented words).
Gait parameters will be measured using the BTS G-Walk wearable sensor system, which records accelerometric data at the lumbar level (L4-L5) and calculates temporospatial parameters. Gait variability will be quantified using the coefficient of variation formula, and gait symmetry will be determined using symmetry index calculations.
The primary outcomes are gait variability and gait symmetry across the three walking conditions. Secondary outcomes include pain characteristics, the Neck Disability Index (NDI), and the Bournemouth Neck Questionnaire (BNQ).
The study hypothesizes that both motor and cognitive dual-task conditions will significantly affect gait variability and symmetry in individuals with NSNP, and these effects will differ from those observed in healthy controls. Findings are expected to improve understanding of motor control alterations in NSNP and provide guidance for individualized rehabilitation programs and therapeutic interventions.
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 3 months
Pain Intensity
Neck pain intensity measured using the Visual Analog Scale (VAS, 0-10).
Measured: 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.
Measured: 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.
Measured: Assessed at baseline (only in NSNP group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jun 2025
- Primary completion15 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Busra Kalkan Balak, Principal investigator, Yuksek Ihtisas UniversityElıf Sena Colak, Principal investigator, Yuksek Ihtisas UniversityAslı Isıkdemır, Principal investigator, Yuksek Ihtisas UniversityDemet Cıhan, Principal investigator, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158281
- Sponsor's protocol ID
- non-spesific neck pain
- Status last verified
- May 2026
- First submitted
- 28 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Dual-Tasking on Gait Variability and Symmetry in Individuals With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT07158281
- Acronym / sponsor ID
- non-spesific neck pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Yuksek Ihtisas University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each participant will complete three walking conditions:
Single-task walking (walking at a self-selected pace), Motor dual-task walking (walking while carrying a tray with a glass of water), and Cognitive dual-task walking (walking while verbally reporting the number of letters in presented words).
Gait parameters will be measured using the BTS G-Walk wearable sensor system, which records accelerometric data at the lumbar level (L4-L5) and calculates temporospatial parameters. Gait variability will be quantified using the coefficient of variation formula, and gait symmetry will be determined using symmetry index calculations.
The primary outcomes are gait variability and gait symmetry across the three walking conditions. Secondary outcomes include pain characteristics, the Neck Disability Index (NDI), and the Bournemouth Neck Questionnaire (BNQ).
The study hypothesizes that both motor and cognitive dual-task conditions will significantly affect gait variability and symmetry in individuals with NSNP, and these effects will differ from those observed in healthy controls. Findings are expected to improve understanding of motor control alterations in NSNP and provide guidance for individualized rehabilitation programs and therapeutic interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- for NSNP group:
- for the Healthy Control group
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait Variability
Time frame: up to 3 months
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.
Gait Symmetry
Time frame: up to 3 months
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.
Pain Intensity
Time frame: Assessed at baseline.
Neck pain intensity measured using the Visual Analog Scale (VAS, 0-10).
Neck Disability Index (NDI)
Time frame: Assessed at baseline (only in NSNP group).
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.
Bournemouth Neck Questionnaire (BNQ)
Time frame: Assessed at baseline (only in NSNP group).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Busra Kalkan Balak principal investigator
Yuksek Ihtisas University
Elıf Sena Colak principal investigator
Yuksek Ihtisas University
Aslı Isıkdemır principal investigator
Yuksek Ihtisas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Gait, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Variability (time frame: up to 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.