NCT05829564

Brief Summary

The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals with chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

March 8, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

22 days

First QC Date

March 8, 2023

Last Update Submit

March 27, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Joint position sense error

    Proprioception in all cervical directions will assessed by Cervical Range of Motion device.

    Change from Baseline balance after 4 weeks/10 sessions.

  • Baropodometer assessments-Pressure distribution

    Pressure distribution will assess with FreeMed baropodometric platform and will record as percentage.

    Change from Baseline proprioception after 4 weeks/10 sessions.

  • Baropodometer assessments- Center of gravity

    Center of gravity will assess with FreeMed baropodometric platform and will record as mm.

    Change from Baseline proprioception after 4 weeks/10 sessions.

  • Baropodometer assessments- Oscillations

    Oscillations will assess with FreeMed baropodometric platform.

    Change from Baseline proprioception after 4 weeks/10 sessions.

  • Baropodometer assessments- Sway velocity

    Sway velocity will assess with FreeMed baropodometric platform and will record as degrees.

    Change from Baseline proprioception after 4 weeks/10 sessions.

  • Functional Balance

    10 meter walking speed and four square step-test will be combined to report dynamic balance.

    Change from Baseline proprioception after 4 weeks/10 sessions.

Secondary Outcomes (4)

  • Cervical Pain

    Change from Baseline cervical pain after 4 weeks/ 10 sessions.

  • Functional disability

    Change from Baseline functional disability after 4 weeks/ 10 sessions.

  • quality of life about cervical pain

    Change from Baseline quality of life about cervical pain after 4 weeks/ 10 sessions.

  • Global perceived effect

    Change from Baseline Global perceived effect after 4 weeks/ 10 sessions.

Study Arms (3)

virtual reality+Exercise

EXPERIMENTAL

An exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups. The virtual reality group will performe virtual reality for an additional 20 minutes. (Oculus GO)

Other: virtual realityOther: exercise

cervical mobilization+Exercise

EXPERIMENTAL

An exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups. Mobilization techniques that will mobilize the cervical region will be applied to the cervical mobilization group for 20 minutes.

Other: cervical mobilizationOther: exercise

Control

OTHER

Control group will only perform an exercise program.

Other: exercise

Interventions

The individuals participating in the study will experience virtual reality.

virtual reality+Exercise

The individuals participating in the study will be applied cervical mobilization techniques.

cervical mobilization+Exercise

The individuals participating in the study will performed neck-specific exercises.

Controlcervical mobilization+Exercisevirtual reality+Exercise

Eligibility Criteria

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

You may qualify if:

  • Neck pain persisting for at least 3 months
  • Being between the ages of 18-65,
  • Being sedentary (not included in any physical therapy program in the last 6 months), -\>10 points from the Neck Disability Index

You may not qualify if:

  • History of previous spinal surgery
  • Neurological, cardiopulmonary, musculoskeletal disease affecting physical performance
  • Any pathology in the shoulder joint
  • Spinal trauma history
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Oge

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist, Prof

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 25, 2023

Study Start

May 10, 2023

Primary Completion

June 1, 2023

Study Completion

September 15, 2023

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations