Effectiveness of a Visual Feedback Exercise Program Following Lumbar Surgery
Efficacy of Laser Pointer-Guided Visual Feedback Stabilization Exercise Program After Lumbar Microdiscectomy Surgery: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: İsmet Tümtürk, MSc
- Phone Number: +90 537 388 56 81
- Email: fztismet@gmail.com
Study Locations
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Antalya, Turkey (Türkiye)
- Recruiting
- Antalya Provincal Health Directorate Antalya Training and Research Hospital
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Contact:
- Cezmi Türk, Dr
- Phone Number: +90 533 234 25 93
- Email: cezmicagri.turk@sbu.edu.tr
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be between 18 and 65 years of age
- Patients who underwent lumbar microdiscectomy surgery
- Individuals who are literate in Turkish
Exclusion Criteria:
- Patients who have previously undergone lumbar disc herniation surgery
- The surgical procedure involving fusion has been performed.
- Having a body mass index above 30
- Suspected or confirmed tumors in the lumbar spine and spinal canal
- Severe heart failure and cerebrovascular accident
- The presence of cauda equina syndrome and concomitant diseases of the lumbar spine
- The presence of heart conditions, orthopedic contraindications, or systemic diseases that could prevent participation in the exercise program
- Refusing to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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Experimental: Laser-Guided Exercise Group
Participants received a supervised stabilization exercise program guided by visual feedback using a laser pointer, in addition to standard postoperative care following lumbar microdiscectomy surgery.
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Participants undergo supervised stabilization exercises for a total of 24 sessions over 8 weeks, starting 6 weeks after lumbar microdiscectomy surgery, 3 days a week.
The exercises will be performed with visual feedback provided by a laser pointer placed on the lumbar region.
Participants will be asked to keep the laser pointer fixed on a designated point or line on the reference diagram in front of them during the exercises.
The program includes posterior pelvic tilt, partial sit-ups, bird-dog, abdominal bracing in the supine position (progression with limb movements), straight and side planks, bridge building, pelvic floor, and diaphragmatic breathing exercises.
Repetitive exercises will be performed in 3 sets of 10 repetitions, while plank exercises will initially be performed in 3 repetitions of 15-30 seconds, with progression based on the individual's performance and weeks.
All participants will be provided with a post-operative training program in video format.
Other Names:
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Active Comparator: Control Group
Participants received a supervised stabilization exercise program without standard postoperative care, back training, or visual feedback following lumbar microdiscectomy surgery.
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Starting 6 weeks after surgery, a supervised stabilization exercise program consisting of 24 sessions over 8 weeks, 3 days a week, will be implemented.
The same exercises as in the laser group will be performed, but without the use of visual feedback.
All participants will be provided with a post-operative training program in video format.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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It will be assessed using the Numerical Rating Scale (NRS).
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Disability Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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It will be measured using the Oswestry Disability Index (ODI).
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Lumbar Proprioception Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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It will be measured using a smartphone-based inclinometer application.
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Back Awareness Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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It will be assessed using the Fremantle Back Awareness Questionnaire.
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trunk Muscle Endurance Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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The McGill Endurance Tests will measure the endurance of the trunk flexor and lateral muscles.
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Lower Extremity Reaction Time Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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The motor response time to visual stimuli will be evaluated using the FITLIGHT® system.
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Balance Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Static postural control will be measured using the one-leg stance test.
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Functional Performance Assessment
Time Frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Functional mobility will be assessed using the timed up and go test.
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All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Level of compliance with educational recommendations
Time Frame: Postoperative week 6
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Participants' level of compliance with the back training and daily life recommendations provided to them during the postoperative period will be assessed using a self-report form.
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Postoperative week 6
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Additional interventions
Time Frame: Up to 8 weeks
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Participants will be asked whether they are receiving any other physical therapy, exercise program, or conservative treatment, and this information will be recorded.
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Up to 8 weeks
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Adverse event and adverse reaction monitoring
Time Frame: Up to 8 weeks
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Any increase in pain, musculoskeletal complaints, or other potential adverse events that may occur during the exercise will be questioned and recorded during the sessions.
Intervention will be terminated if necessary.
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Up to 8 weeks
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Drop-out and withdrawal reasons
Time Frame: Up to 8 weeks
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The reasons for participants leaving the study (lack of motivation, health issues, incompatibility, etc.) will be documented and reported in the analyses.
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Up to 8 weeks
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Adherence to exercise sessions
Time Frame: Post-intervention (postoperative week 14)
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The therapist will record participants' level of attendance at exercise sessions.
Attendance at at least 80% of total sessions will be considered sufficient exercise compliance.
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Post-intervention (postoperative week 14)
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Sociodemographic and clinical characteristics
Time Frame: Post-operative day 1
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Gender
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Post-operative day 1
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Sociodemographic and clinical characteristics
Time Frame: Post-operative day 1
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Age (years)
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Post-operative day 1
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Sociodemographic and clinical characteristics
Time Frame: Post-operative day 1
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Body mass index (kg/m2)
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Post-operative day 1
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: İsmet Tümtürk, MSc, Suleyman Demirel University
- Study Director: Ferdi Başkurt, PhD, Suleyman Demirel University
- Principal Investigator: Cezmi Türk, Antalya Provincal Health Directorate Antalya Training and Research Hospital
- Principal Investigator: Fatih Özden, Muğla Sıtkı Koçman University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Laser Pointer Exercise
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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