- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07603609
Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain
Effects of a Sensorimotor Training Protocol Using a Mobilized Balance Platform on Proprioceptive System, Movement Control, and Quality of Life in Patients With Chronic Low Back Pain
This randomized controlled study aims to investigate the effects of a sensorimotor training protocol using a mobilized balance platform device on proprioceptive system function, movement control, balance, physical performance, pain severity, and quality of life in patients with chronic low back pain. A total of 44 patients with chronic low back pain will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to either a sensorimotor training group or a control group. The intervention group will receive sensorimotor training using the Huber 360 balance system, while the control group will perform a home exercise program including stretching, spinal mobility, lumbopelvic control, and balance exercises.
Pain severity, proprioception, functional status, balance, physical performance, and quality of life will be assessed before and after treatment by an assessor blinded to group allocation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sefa Gumruk Aslan
- Phone Number: +903122911503
- Email: sefagumrukk@gmail.com
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Gaziler physical therapy and rehabilitation hospital
-
Contact:
- Sefa Gumruk Aslan
- Phone Number: +903122911503
- Email: sefagumrukk@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged between 18 and 55 years
- Presence of chronic low back pain lasting at least 3 months
- Pain intensity score of 3 or higher on the Visual Analog Scale (VAS)
- Individuals with sufficient cognitive ability to understand and follow study procedures
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Participation in a similar training program within the last 12 months
- History of lower extremity or spinal surgery
- Presence of non-mechanical low back pain, inflammatory disease, or tumor
- Uncontrolled hypertension or cardiac disease
- History of malignancy
- Presence of radicular symptoms associated with low back pain
- Progressive neurological deficits
- Neurogenic claudication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Home Exercise Program
Participants in this group will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
|
Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
|
|
Experimental: Huber 360 Sensorimotor Training
Participants in this group will receive a sensorimotor training protocol using the Huber 360 balance system.
The intervention will include progressive rotational and oscillatory exercises aimed at improving proprioception, balance, neuromuscular control, and movement control.
Sessions will be performed for 30 minutes, twice weekly for 5 weeks.
|
Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
Participants will receive sensorimotor training using the Huber 360 balance system.
The protocol will include progressive rotational and oscillatory exercises designed to improve proprioception, balance, neuromuscular control, and movement control in patients with chronic low back pain.
Sessions will be performed for 30 minutes, twice weekly for 5 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Proprioception Assessment
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
Lumbar proprioception will be assessed using lumbar repositioning tests at 60 degrees flexion and 15 degrees extension.
Participants will be asked to reproduce target lumbar positions, and the angular repositioning error will be recorded.
Lower repositioning error values indicate better lumbar proprioceptive accuracy.
|
Before treatment and immediately after completion of the 5-week intervention program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Severity Assessed by Visual Analog Scale
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain severity.
|
Before treatment and immediately after completion of the 5-week intervention program
|
|
Functional Status Assessed by Oswestry Disability Index
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI).
Higher scores indicate greater disability.
|
Before treatment and immediately after completion of the 5-week intervention program
|
|
Balance and Limits of Stability Assessed by Huber 360
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
Static balance, dynamic balance, and limits of stability will be assessed using the Huber 360 balance system.
Better balance performance and improved stability limits indicate better postural control.
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Before treatment and immediately after completion of the 5-week intervention program
|
|
Lumbar Flexion Range of Motion
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
Physical performance will be assessed using a Physical Performance Test Battery including lumbar flexion range of motion, 50-step walking test, 5-minute walking test, five-repetition sit-to-stand test, ten-repetition trunk flexion test, and forward reaching with weight.
|
Before treatment and immediately after completion of the 5-week intervention program
|
|
Quality of Life Assessed by Short Form-36
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
Quality of life will be assessed using the Short Form-36 (SF-36).
Higher scores indicate better health-related quality of life.
|
Before treatment and immediately after completion of the 5-week intervention program
|
|
50-Step Walking Test
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
he time required to complete the 50-step walking test will be recorded in seconds
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Before treatment and immediately after completion of the 5-week intervention program
|
|
Five-Minute Walking Test
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
The time required to complete five sit-to-stand repetitions will be recorded in seconds.
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Before treatment and immediately after completion of the 5-week intervention program
|
|
Ten-Repetition Trunk Flexion Test
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
|
The time required to complete ten trunk flexion repetitions will be recorded in seconds.
|
Before treatment and immediately after completion of the 5-week intervention program
|
|
Forward Reaching with Weight Test
Time Frame: Before treatment and immediately after completion of the 5-week intervention program
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Forward reaching distance while holding weight will be measured in centimeters.
|
Before treatment and immediately after completion of the 5-week intervention program
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLBP-MBP-2026
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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