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临床试验/NCT07158281
NCT07158281已完成不适用

Investigation of the Effects of Dual-Tasking on Gait Variability and Symmetry in Individuals With Nonspecific Neck Pain

Hacettepe University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Gait Variability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •(applies to both groups):
  • •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

研究组 & 干预措施

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.

结局指标

主要结局

Gait Variability

时间窗: 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

时间窗: 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

时间窗: Assessed at baseline.

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

Bournemouth Neck Questionnaire (BNQ)

时间窗: 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.

Gait Variability

时间窗: 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

时间窗: 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

时间窗: Assessed at baseline.

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

Bournemouth Neck Questionnaire (BNQ)

时间窗: 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.

Neck Disability Index (NDI)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Güngör Beyza ÖZVAR

Principal Investıgator

Hacettepe University

研究点 (1)

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