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The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation

Primary Purpose

Lumbar Disc Herniation, Balance; Distorted

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise treatment
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar Disc Herniation,, Chronic Period, Balance,, Core Stabilization,, Proprioceptive Sense

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Individuals aged 45 and over with a diagnosis of Lumbar Disc Herniation, Not having any communication barriers (sight, hearing, hearing), Have not undergone any surgical procedure in the last 6 months, Patients who volunteered to participate in the study Exclusion Criteria: Those who do not want to participate in the study, Individuals whose age is unsuitable, Individuals who continue to receive a therapeutic exercise therapy, Individuals with a neurological condition that may affect ankle muscle strength and sensation

Sites / Locations

  • As Physiotherapy Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment group

control group

Arm Description

treatment group: core stabilization exercises used to improve balance

this group members have continued their normal lives

Outcomes

Primary Outcome Measures

Change from baseline in static balance on Diasu Gait Analysis Device at Week 8
To evaluate static balance looking at oscillation length in 1 minute Change= (Week 8 score - Baseline score)
Change from baseline in weight bearing on Diasu Gait Analysis Device at Week 8
To evaluate weight bearing looking at weight percent for each foot Change= (Week 8 score - Baseline score)
Change from baseline in static and dynamic balance on Berg Balance Test at Week 8
To evaluate static and dynamic balance. It consists of evaluating 14 activities implemented by direct observation of performance. Each item is scored between 0-4. 0 represents the worst and 4 the best. The total highest score is 56. Scores of 45 and below indicate a risk of falling. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and functionality on Timed Up and Go Test at Week 8
To evaluate dynamic balance and functionality. The person is asked to get up from the stool, to walk with a safe and normal walking speed, to turn and to sit on the stool again. The distance between two stools is fixed at 3 meters. The application time is recorded in seconds. A shorter duration indicates better balance and mobility. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and functionality on Y Balance Test at Week 8
To evaluate dynamic balance and functionality. While standing on one foot, he is asked to take steps with the other foot first anteriorly, then posterolaterally, and finally in the posteromedial direction. At this time, care must be taken that the foot on the ground does not rise from the ground and the balance is not disturbed. The test is repeated 3 times in each direction and the average is taken and recorded in cm. The same measurement is applied to the other foot in the same way. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and functionality on Functional Reach Test at Week 8
To evaluate dynamic balance and functionality. The individual is asked to stand upright for the test and to extend the arm to be measured forward. As the starting point, the 3rd fingertip strip is brought to the 0 point on the tape measure. The tape measure is fixed by the physiotherapist and the patient is asked to lie on the tape measure without losing the contact of the feet with the ground. The test is repeated 3 times and the best distance is recorded in cm. The test is repeated 3 times and the best distance is recorded in cm for the right and left measurement. Change= (Week 8 score - Baseline score)
Change from baseline in dynamic balance and for assessing falls on Tinetti Fall Efficiency Scale at Week 8
To evaluate dynamic balance and for assessing falls. It is a questionnaire consisting of 10 questions measuring A score between 1-10 is given. 1 is scored as very safe and 10 is scored as very high fear of falling. The total highest score is recorded as 100. Change= (Week 8 score - Baseline score)
Change from baseline in pain on Mcgill pain Scale at Week 8
To evaluate pain degree. It is a questionnaire that questions the severity of the pain, its location, its first relationship over time, the sensation it creates in people, and whether it is livable pain for individuals. Change= (Week 8 score - Baseline score)
Change from baseline in pain on Visual Analog Scale at Week 8
To evaluate pain degree. A score between 0-10 is given. 0 means no pain and 10 is scored as excruciating pain. Change= (Week 8 score - Baseline score)
Change from baseline in proprioceptive sensation on ankle joint position sense at Week 8
To evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion. Change= (Week 8 score - Baseline score)
Change from baseline in quality of life and functionality on Nottingham Health Profile at Week 8
To assess quality of life and functionality. It is a scale that questions psychological well-being from different aspects such as physical activity, pain, emotional state, sleep, social life, energy. Short answers are given as yes or no. A person can get a maximum of 600 points. An increase in the score obtained means that the level of quality of life decreases. Change= (Week 8 score - Baseline score)
Change from baseline in quality of life and functionality on Oswestry Disorder Scale at Week 8
To assess quality of life and functionality. It is a questionnaire consisting of 10 items. The person can get points between 0-10 from each item. 0 represents the best level and 5 represents the worst level. The total score is a maximum of 100. As the score increases, it is shown that the functionality of the person worsens and the level of disability increases. Change= (Week 8 score - Baseline score)
A self-prepared form
For patient demographic information,

Secondary Outcome Measures

Full Information

First Posted
October 15, 2022
Last Updated
November 29, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT05634330
Brief Title
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
Official Title
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation
Detailed Description
This study was carried out to examine the effect of core stabilization exercises on balance and quality of life in the chronic period in individuals with lumbar disc herniation. Forty patients aged 45-65 years who had been diagnosed with lumbar disc herniation at least one year ago were included in the study. By randomization, they were divided into 2 groups of 20 people, each being the treatment and the control group. A self-prepared form for patient demographic information, McGill Pain Scale and Visual Analog Scale(VAS) for pain assessment; Diasu Gait Analysis Device and Berg Balance Scale for static balance assessment; Timed Up and Go Test, Y Balance Diagram, Functional Reach Test to evaluate dynamic balance; Tinetti Fall Efficiency Scale for assessing falls; The Oswestry Disorder Scale and Nottingham Health Profile were used to assess quality of life and functionality; to evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion. After the questionnaires and measurement tools were completed, the patients were included in the program. While the patients in the control group continued their routine lives, the modified pilates exercise program focused on core stabilization was applied to the patients in the treatment group for 8 weeks, 2 days a week for 50 minutes and in 4 groups. After the treatment process was completed, the questionnaires and measurements were repeated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Balance; Distorted
Keywords
Lumbar Disc Herniation,, Chronic Period, Balance,, Core Stabilization,, Proprioceptive Sense

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two group. one of group for exercise and the other group is for control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
treatment group: core stabilization exercises used to improve balance
Arm Title
control group
Arm Type
No Intervention
Arm Description
this group members have continued their normal lives
Intervention Type
Other
Intervention Name(s)
exercise treatment
Intervention Description
core stabilization exercise
Primary Outcome Measure Information:
Title
Change from baseline in static balance on Diasu Gait Analysis Device at Week 8
Description
To evaluate static balance looking at oscillation length in 1 minute Change= (Week 8 score - Baseline score)
Time Frame
baseline and Week 8
Title
Change from baseline in weight bearing on Diasu Gait Analysis Device at Week 8
Description
To evaluate weight bearing looking at weight percent for each foot Change= (Week 8 score - Baseline score)
Time Frame
baseline and Week 8
Title
Change from baseline in static and dynamic balance on Berg Balance Test at Week 8
Description
To evaluate static and dynamic balance. It consists of evaluating 14 activities implemented by direct observation of performance. Each item is scored between 0-4. 0 represents the worst and 4 the best. The total highest score is 56. Scores of 45 and below indicate a risk of falling. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in dynamic balance and functionality on Timed Up and Go Test at Week 8
Description
To evaluate dynamic balance and functionality. The person is asked to get up from the stool, to walk with a safe and normal walking speed, to turn and to sit on the stool again. The distance between two stools is fixed at 3 meters. The application time is recorded in seconds. A shorter duration indicates better balance and mobility. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in dynamic balance and functionality on Y Balance Test at Week 8
Description
To evaluate dynamic balance and functionality. While standing on one foot, he is asked to take steps with the other foot first anteriorly, then posterolaterally, and finally in the posteromedial direction. At this time, care must be taken that the foot on the ground does not rise from the ground and the balance is not disturbed. The test is repeated 3 times in each direction and the average is taken and recorded in cm. The same measurement is applied to the other foot in the same way. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in dynamic balance and functionality on Functional Reach Test at Week 8
Description
To evaluate dynamic balance and functionality. The individual is asked to stand upright for the test and to extend the arm to be measured forward. As the starting point, the 3rd fingertip strip is brought to the 0 point on the tape measure. The tape measure is fixed by the physiotherapist and the patient is asked to lie on the tape measure without losing the contact of the feet with the ground. The test is repeated 3 times and the best distance is recorded in cm. The test is repeated 3 times and the best distance is recorded in cm for the right and left measurement. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in dynamic balance and for assessing falls on Tinetti Fall Efficiency Scale at Week 8
Description
To evaluate dynamic balance and for assessing falls. It is a questionnaire consisting of 10 questions measuring A score between 1-10 is given. 1 is scored as very safe and 10 is scored as very high fear of falling. The total highest score is recorded as 100. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in pain on Mcgill pain Scale at Week 8
Description
To evaluate pain degree. It is a questionnaire that questions the severity of the pain, its location, its first relationship over time, the sensation it creates in people, and whether it is livable pain for individuals. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in pain on Visual Analog Scale at Week 8
Description
To evaluate pain degree. A score between 0-10 is given. 0 means no pain and 10 is scored as excruciating pain. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in proprioceptive sensation on ankle joint position sense at Week 8
Description
To evaluate proprioceptive sensation, ankle joint position sense was measured in standing, neutral position (0˚) and angular measurement in 10˚ dorsiflexion. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in quality of life and functionality on Nottingham Health Profile at Week 8
Description
To assess quality of life and functionality. It is a scale that questions psychological well-being from different aspects such as physical activity, pain, emotional state, sleep, social life, energy. Short answers are given as yes or no. A person can get a maximum of 600 points. An increase in the score obtained means that the level of quality of life decreases. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
Change from baseline in quality of life and functionality on Oswestry Disorder Scale at Week 8
Description
To assess quality of life and functionality. It is a questionnaire consisting of 10 items. The person can get points between 0-10 from each item. 0 represents the best level and 5 represents the worst level. The total score is a maximum of 100. As the score increases, it is shown that the functionality of the person worsens and the level of disability increases. Change= (Week 8 score - Baseline score)
Time Frame
Baseline and Week 8
Title
A self-prepared form
Description
For patient demographic information,
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged 45 and over with a diagnosis of Lumbar Disc Herniation, Not having any communication barriers (sight, hearing, hearing), Have not undergone any surgical procedure in the last 6 months, Patients who volunteered to participate in the study Exclusion Criteria: Those who do not want to participate in the study, Individuals whose age is unsuitable, Individuals who continue to receive a therapeutic exercise therapy, Individuals with a neurological condition that may affect ankle muscle strength and sensation
Facility Information:
Facility Name
As Physiotherapy Office
City
Gaziantep
State/Province
Gazi̇antep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effect of Core Stabilization Exercises on Balance and Quality of Life in Chronic Period in Individuals With Lumbar Disc Herniation

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