NCT05788263

Brief Summary

The aim of this study is to examine the effects of neuroscience-based exercise approaches on pain, disability and gait parameters in individuals with non-specific chronic neck pain. Material- Methods Demographic data, gait parameters, Dizabilty level and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Neck Disability Index and photometer, respectively. The evaluations were performed 2 times before and after the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

March 15, 2023

Last Update Submit

April 3, 2024

Conditions

Keywords

Neuroscience based exercisesChronic neck paingait parameters

Outcome Measures

Primary Outcomes (3)

  • craniovertebral angle degree

    Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.

    1 minute

  • Legsystm

    The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm. The device consists of two sensors. The sensors are placed 3-5 cm above the ankle of the subject to be tested with the help of velcro. The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth. The software analyzes the raw data it receives from the device and turns it into results.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.

    1 minute

  • Neck Disability Index

    It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.

    3 minutes

Study Arms (3)

Craniovertebral angle assesment

EXPERIMENTAL

Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.

Other: neuroscience based aproach

Spatio-temporal gait analyz (LEGSystm)

EXPERIMENTAL

The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm. The device consists of two sensors. The sensors are placed 3-5 cm above the ankle of the subject to be tested with the help of velcro. The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth. The software analyzes the raw data it receives from the device and turns it into results.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time

Other: neuroscience based aproach

Neck Disabilty Index

EXPERIMENTAL

It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.

Other: neuroscience based aproach

Interventions

exercise for pain

Craniovertebral angle assesmentNeck Disabilty IndexSpatio-temporal gait analyz (LEGSystm)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosing with chronic non-specific neck pain
  • Volunteer to participate in the study
  • beetwen 18-25 years old

You may not qualify if:

  • have had any cervical area surgery
  • having any disease that would affect the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, 20100, Turkey (Türkiye)

Location

Study Officials

  • fatih tekin, assist prof

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: basic randomization via spss 24.00 program
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

March 1, 2023

Primary Completion

December 20, 2023

Study Completion

December 31, 2023

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations