- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463588
Individuals With Lumbar Disc Hernia Exercising With Virtual Reality Glasses
The Effect of Exercise Conducted With Virtual Reality Glasses on Pain, Daily Life Activities and Quality of Life In Individuals With Lumbar Disc Herniation
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this research; exercise performed with virtual reality glasses for individuals with lumbar disc herniation; The aim of this study is to examine the effects on pain, activities of daily living, quality of life and falling.
This research was carried out experimentally with pretest-posttest control group.
The research was carried out between December 2019 and August 2022. The research was carried out in the Physical Therapy Unit of Erzurum Atatürk University Health Practice and Research Center.
The universe of the research; It consisted of 68 patients with LDH who came to Atatürk University Health Application and Research Center Physical Therapy and Rehabilitation Unit between 13 September 2022 and 7 January 2022.
n data collection, "Patient Identification Form" (Appendix-5), "Visual Analog Scale" (Appendix-6), "Oswestry Disability Index" (Appendix-7), "SF-36 Quality of Life Scale" (Appendix-8) and Falling Risk Score result is used.The patients in the experimental and control groups were first given training on protection of back health and exercise.
The patients in the experimental group did waist exercises with virtual reality glasses for 2 sessions, 28 sessions in total, every weekday.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Palandöken
-
Erzurum, Palandöken, Turkey, 25070
- serap Buztepe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being literate.
- Not having a physical disability that prevents them from doing the exercises.
- Not have an uncontrolled chronic or acute illness.
- Not having a vision problem that cannot be controlled by assistive methods.
- Not having a vertigo problem
- To be cognitively competent.
- Not having any musculoskeletal surgery in the last 6 months
- Not having knee joint disease
- To be able to complete the measurement with the balance device
- Having a body mass index below 40
Exclusion Criteria:
- To have a medium and high fall risk score in the measurement made with the balance device
- Experiencing chronic pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Collection of pre-test data from the experimental and control groups
Asking vas, ODI, sf-36 quality of life scale questions
|
GIVE PATIENTS EXERCISE WITH A 360 DEGREE EXERCISE VIDEO INSIDE VIRTUAL REALITY EYES. Exercising with the training material taught at the beginning of the training
Other Names:
|
Experimental: Calculation of the pre-test fall risk index
Calculation of patients' fall risk indices
|
GIVE PATIENTS EXERCISE WITH A 360 DEGREE EXERCISE VIDEO INSIDE VIRTUAL REALITY EYES. Exercising with the training material taught at the beginning of the training
Other Names:
|
Experimental: giving back health education to the experimental and control groups
Back health training was given to both groups, and the experimental group was given training on using virtual glasses.
|
GIVE PATIENTS EXERCISE WITH A 360 DEGREE EXERCISE VIDEO INSIDE VIRTUAL REALITY EYES. Exercising with the training material taught at the beginning of the training
Other Names:
|
Experimental: collection of post-test data for the experimental and control group
Asking vas, ODI, sf-36 quality of life scale questions
|
GIVE PATIENTS EXERCISE WITH A 360 DEGREE EXERCISE VIDEO INSIDE VIRTUAL REALITY EYES. Exercising with the training material taught at the beginning of the training
Other Names:
|
Experimental: Calculation of the post-test fall risk index
Calculation of patients' fall risk indices
|
GIVE PATIENTS EXERCISE WITH A 360 DEGREE EXERCISE VIDEO INSIDE VIRTUAL REALITY EYES. Exercising with the training material taught at the beginning of the training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Filling in the Visual Analog scale form before the intervention fort the LDH patients icluded in the study
Time Frame: Before starting the first treatment in the physical therapy unit (first day)
|
The minimum score to be taken is 0 and the maximum score is 10.
İt is known that as the score obtained increases,the pain felt by the patient increases
|
Before starting the first treatment in the physical therapy unit (first day)
|
Filling in the SF-36 Ouality of life scale form before the intervention fort the LDH patients icluded in the study
Time Frame: Before starting the first treatment in the physical therapy unit (first day)
|
The minimum score obtained from the SF-36 quality of life scale is 0 and the maximum score is 100.
The higher the score, the higher the patient's quality of life
|
Before starting the first treatment in the physical therapy unit (first day)
|
Filling in the Oswestry Disability Index form before the intervention fort the LDH patients icluded in the study
Time Frame: Before starting the first treatment in the physical therapy unit (first day)
|
The minimum score obtained from the Oswestry Disability Index is 0 and the maximum score is 50.
The lower the score, the greater the independence of the patient in his daily activities
|
Before starting the first treatment in the physical therapy unit (first day)
|
Calculation of the fall risk index based on % points before the intervention fort he LDH patients included in the study
Time Frame: Before starting the first treatment in the physical therapy unit (first day)
|
The lowest score to be taken from the risk index is 0 and the highest score is 100.
The lower the Score received, the lower the risk
|
Before starting the first treatment in the physical therapy unit (first day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Filling the Visual Analog scale form for LDH patients who have completed their 3-week intervention
Time Frame: After 3 weeks of intervention
|
The minimum score to be taken is 0 and the maximum score is 10.
İt is known that as the score obtained increases,the pain felt by the patient increases
|
After 3 weeks of intervention
|
Filling the Oswestry Disability Index form for LDH patients who have completed their 3-week intervention
Time Frame: After 3 weeks of intervention
|
The minimum score obtained from the Oswestry Disability Index is 0 and the maximum score is 50.
The lower the score, the greater the independence of the patient in his daily activities
|
After 3 weeks of intervention
|
Filling the SF-36 Ouality of life scale form for LDH patients who have completed their 3-week intervention
Time Frame: After 3 weeks of intervention
|
The minimum score obtained from the SF-36 quality of life scale is 0 and the maximum score is 100.
The higher the score, the higher the patient's quality of life
|
After 3 weeks of intervention
|
Calculation of the fall risk index of LDH patients over % points after 3 weeks of intervention
Time Frame: After 3 weeks of intervention
|
The lowest score to be taken from the risk index is 0 and the highest score is 100.
The lower the Score received, the lower the risk
|
After 3 weeks of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- Atatürk university-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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