- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495475
Mobile App-Supported Exercise Program For Mechanical Low Back Pain
Effect of a Mobile Application-Supported Home Exercise Program on Posture, Balance, Pain and Functionality in Individuals With Mechanical Low Back Pain
Mechanical low back pain is one of the most common musculoskeletal disorders affecting daily activities and quality of life. Home exercise programs are frequently recommended in the management of low back pain; however, adherence to these programs is often limited. Mobile health applications may enhance adherence by providing exercise demonstrations, reminders, and monitoring tools.
The aim of this study is to investigate the effects of a mobile application-supported home exercise program on posture, balance, pain, and functional status in individuals with mechanical low back pain. Participants with chronic mechanical low back pain will be randomly assigned to two groups. Both groups will receive the same home exercise program. The control group will receive the exercises in printed format, while the experimental group will follow the program through the E-Exercise mobile application that includes exercise videos, reminders, and progress tracking.
Participants will be evaluated before the intervention and after six weeks of exercise training. Outcome measures will include flexibility, posture, balance, pain intensity, and functional disability. The results of this study may contribute to improving adherence to home exercise programs and promoting the use of digital health technologies in physiotherapy practice.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mechanical low back pain is a common musculoskeletal condition that may negatively affect posture, balance, pain perception, physical function, and quality of life. Home exercise programs are widely used in physiotherapy for the management of mechanical low back pain because they are practical, accessible, and cost-effective. However, poor adherence to home exercise programs and difficulties in performing exercises correctly may reduce treatment effectiveness.
This study is designed to investigate whether a mobile application-supported home exercise program provides additional benefits compared with a conventional printed home exercise program in individuals with chronic mechanical low back pain. The mobile application developed for this study, called E-Exercise, includes video-based exercise instructions, reminder notifications, and an exercise tracking component that allows participants to mark completed exercises. These features are intended to improve exercise adherence and support correct exercise performance at home.
A total of 50 participants with chronic mechanical low back pain will be randomly assigned to either the experimental group or the control group. Both groups will receive the same exercise content prepared by a physiotherapist and will perform the exercises 3 days per week for 6 weeks. The control group will receive the exercise program in printed form, whereas the experimental group will use the mobile application.
Participants will be evaluated before the intervention and at the end of the 6-week program. Outcome measures will include flexibility assessed by the Sit and Reach Test, Straight Leg Raise Test, and Modified Schober Test; posture assessed by PostureScreenLite; postural balance assessed by the Bertec Balance Legacy System; pain assessed by the Visual Analog Scale and Pain Catastrophizing Scale; functional disability assessed by the Oswestry Disability Index; and health-related quality of life assessed by the SF-12. This study is expected to provide evidence on whether mobile health support can improve adherence and clinical outcomes in home-based physiotherapy programs for individuals with mechanical low back pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ece ACAR, PhD
- Phone Number: +905457925035
- Email: eceacar@karabuk.edu.tr
Study Contact Backup
- Name: Nidanur Soyturk, Student
- Phone Number: +905466672727
- Email: 2211502614@ogrenci.karabuk.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged between 18 and 65 years
- Diagnosis of chronic mechanical low back pain lasting longer than 3 months
- Ability to use a smartphone or mobile device
- Willingness to participate in the study and provide informed consent
Exclusion Criteria:
- Cauda equina syndrome
- Long-term corticosteroid use
- Presence of focal neurological deficits associated with disability
- Previous spinal surgery
- Severe neurological or systemic disorders affecting mobility
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: Printed Home Exercise Program
Participants in this group will receive the same home exercise program in printed format.
Exercises will be explained by a physiotherapist and participants will be asked to perform them at home three times per week for six weeks.
|
Participants will receive a printed version of the same home exercise program explained by a physiotherapist.
Participants will perform the exercises at home three times per week for six weeks without mobile application support.
|
|
Experimental: Mobile Application-Supported Home Exercise
Participants in this group will receive a home exercise program supported by the E-Exercise mobile application.
The application provides video demonstrations of exercises, reminder notifications, and exercise tracking.
Participants will perform the exercises three times per week for six weeks.
|
Participants will follow a home exercise program through the E-Exercise mobile application.
The application provides video demonstrations of exercises, reminder notifications, and an exercise tracking feature.
Participants will perform the exercises three times per week for six weeks.
The exercises are designed by a physiotherapist and aim to improve flexibility, posture, balance, pain, and functional status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Baseline and 6 weeks
|
Pain intensity will be assessed using a 10-cm Visual Analog Scale, where 0 indicates no pain and 10 indicates worst possible pain.
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flexibility Measured by Sit and Reach Test (cm)
Time Frame: Baseline and 6 weeks
|
Flexibility will be assessed using the Sit and Reach Test to evaluate hamstring and lower back flexibility.
Results will be recorded in centimeters.
|
Baseline and 6 weeks
|
|
Postural Alignment Measured by PostureScreenLite Mobile Application
Time Frame: Baseline and 6 weeks
|
Postural alignment will be evaluated using the PostureScreenLite mobile application.
Standardized photographs from anterior, posterior, and lateral views will be analyzed to determine postural deviation angles.
|
Baseline and 6 weeks
|
|
Postural Balance Measured by Bertec Balance System (Center of Pressure Parameters)
Time Frame: Baseline and 6 weeks
|
Postural balance will be assessed using the Bertec Balance Legacy System by measuring center of pressure displacement and stability parameters during quiet standing.
|
Baseline and 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MechanicalLumbarApp
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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