NCT05776992

Brief Summary

Posture is defined as the best position formed by the segments that make up the body in a harmonious arrangement with each other. Muscle strength, which is one of the primary factors in providing a static or dynamic posture, is achieved thanks to the antigravity muscles that keep the body upright against gravity. Proper posture is ensured by a good body balance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 6, 2023

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Visual Analogue Scale (VAS)

    The Visual Analogue Scale (VAS) was used to evaluate the severity of pain, and the patients were asked to mark the level of pain they felt before and after the treatment. The VAS is a 10-centimeter straight line, the number 0 (zero) at one end indicates no pain, and the number 10 (ten) at the other end represents unbearable pain. The points marked by the patients were measured with the help of a ruler starting from the 0 point and recorded as numerical values.

    6 weeks

  • Y Balance Test

    Y balance test, a large Y tape is drawn on the flat surface such that the angle between the front and back directions is 135 degrees, and the angle between the two back sides is 90 degrees. The person is asked to place their feet exactly in the center. It is explained that while balancing on one foot, she/he should reach anterior (front), posterolateral (posterior external), and posteromedial (posterior internal) directions with the other foot, and keep her/his weight on a stable foot. Three attempts are made before starting the test

    6 weeks

  • Oswestry Low Back Pain Disability Questionnaire

    It is a questionnaire that aims to evaluate the disability levels and quality of life faced by patients due to low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, standing, sleep, sexual life, social life and travel). Each item is measured on a 6-point rank scale between 0 and 5 points according to the scenarios it contains. At the end of the survey, the scores are summed and the percentage value is calculated for the total score. High score indicates poor functional level.

    6 weeks

  • Algometer

    The Algometer used (JTECH Medical-Algometer Commander-USA, Electronic Algometer) is a digital algometer with an LCD display, which can be used as a wrist unit or desktop system, and where measurements can be made in kilograms or Newtons.

    6 weeks

  • Body Awareness Questionnaire

    In 13 statements, some situations in which people feel about themselves are listed. After reading each statement, they are asked to write the number in the space to the left of the statement, evaluating from 1 to 7 the degree to which the statement is true for them.

    6 weeks

  • Flamingo Static Balance Evaluation Test:

    Flamingo balance test (FBT) is a test used for balance measurements in the Eurofit test battery.

    6 weeks

Study Arms (2)

balance games

EXPERIMENTAL

virtual reality games

Device: Xbox virtual reality games

balance training

ACTIVE COMPARATOR

Biodex balance training

Device: Biodex balance training

Interventions

X-box balance evaluation was implemented in a completely dark and isolated room specially prepared for this treatment and evaluation

balance games

the Biodex Balance System SD has been designed to meet the needs of everyone looking to improve balance, increase agility, develop muscle tone and treat a wide variety of pathologies.

balance training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • with nonspecific chronic low back pain

You may not qualify if:

  • Cognitive impairment
  • Disc herniation
  • Neurological deficit
  • Respiratory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAZAL genç

Istanbul, None Selected, 34353, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Dayanir IO, Birinci T, Kaya Mutlu E, Akcetin MA, Akdemir AO. Comparison of Three Manual Therapy Techniques as Trigger Point Therapy for Chronic Nonspecific Low Back Pain: A Randomized Controlled Pilot Trial. J Altern Complement Med. 2020 Apr;26(4):291-299. doi: 10.1089/acm.2019.0435. Epub 2020 Feb 5.

    PMID: 32023423BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

HAZAL genç, PhD

CONTACT

tuğçe tahmaz, Phd(c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Treatment and assessment in the study was performed by different physiotherapists.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prior to and following the eight-week application, evaluation was conducted
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist PhD

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 20, 2023

Study Start

March 10, 2023

Primary Completion

May 10, 2023

Study Completion

July 2, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations