Antalya Provincal Health Directorate Antalya Training and Research Hospital
Antalya, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07382830
The aim of this study is to compare the effectiveness of stabilization exercises performed with visual feedback guided by a laser pointer after lumbar microdiscectomy surgery with that of standard stabilization exercises. The study, planned as a randomized controlled trial, will include 42 individuals aged 18-65 who have undergone lumbar microdiscectomy. Participants will be divided into two groups: a control group and a laser-guided exercise group. Both groups will undergo supervised stabilization exercises 3 days a week for 8 weeks, starting from the 6th postoperative week. The outcome measures were defined as pain, disability, back awareness, trunk muscle endurance, reaction time, balance, function, and lumbar proprioception. The findings are expected to demonstrate the effectiveness of visual feedback-assisted stabilization exercises in postoperative rehabilitation and contribute to clinical practice.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Antalya, Turkey (Türkiye)
Location status: Recruiting
This study is a randomized controlled trial designed to compare the effects of stabilization exercises performed with laser-guided visual feedback and conventional stabilization exercises in individuals who have undergone lumbar microdiscectomy surgery. A total of 42 participants aged 18-65 years who have undergone lumbar microdiscectomy will be included in the study. Participants will be randomly assigned to either a control group or a laser-guided exercise group. Both groups will receive supervised stabilization exercise programs three times per week for eight weeks, starting from the sixth postoperative week. The exercise content will be similar in both groups, with the laser-guided group receiving additional visual feedback during exercises. Outcome measures will be assessed at baseline and after completion of the intervention. Assessments will include pain, disability, back awareness, trunk muscle endurance, reaction time, balance, functional performance, and lumbar proprioception. The results of this study are expected to contribute to evidence-based postoperative rehabilitation approaches following lumbar microdiscectomy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Laser-Guided Supervised Exercise
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: Control Group
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
It will be assessed using the Numerical Rating Scale (NRS).
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
It will be measured using the Oswestry Disability Index (ODI).
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
It will be measured using a smartphone-based inclinometer application.
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
It will be assessed using the Fremantle Back Awareness Questionnaire.
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
The McGill Endurance Tests will measure the endurance of the trunk flexor and lateral muscles.
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
The motor response time to visual stimuli will be evaluated using the FITLIGHT® system.
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
Static postural control will be measured using the one-leg stance test.
Time frame: All primary and secondary outcomes will be assessed at baseline (postoperative week 6) and post-intervention (postoperative week 14).
Functional mobility will be assessed using the timed up and go test.
Time frame: Postoperative week 6
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.
Time frame: Up to 8 weeks
Participants will be asked whether they are receiving any other physical therapy, exercise program, or conservative treatment, and this information will be recorded.
Time frame: Up to 8 weeks
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.
Time frame: Up to 8 weeks
The reasons for participants leaving the study (lack of motivation, health issues, incompatibility, etc.) will be documented and reported in the analyses.
Time frame: Post-intervention (postoperative week 14)
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.
Time frame: Post-operative day 1
Gender
Time frame: Post-operative day 1
Age (years)
Time frame: Post-operative day 1
Body mass index (kg/m2)
Contact information is provided by the study sponsor or research team.
Suleyman Demirel University
Other
Efficacy of Laser Pointer-Guided Visual Feedback Stabilization Exercise Program After Lumbar Microdiscectomy Surgery: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06851533
Lumbar Microdiscectomy, Nerve Block
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07226700
Agnosia, JOURNAVX
New York, United States
View Trial DetailsNCT07632664
Aged, Lung Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT07561164
Behavior, Hip Fracture Surgery
Hvidovre, Denmark
View Trial Details