An interventional study of Standard Rehabilitation and Task-Specific Gait Training in Lumbar Spinal Stenosis, sponsored by Istanbul Medipol University Hospital. Not yet recruiting. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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This study will test whether adding walking practice to standard rehabilitation improves balance while walking after lower back surgery. The study will include 60 adults aged 30 to 65 who still have difficulty walking or keeping their balance after surgery to relieve pressure on the nerves in the lower back caused by a narrowing of the spinal canal.
Participants will be assigned by chance to one of two groups. One group will receive standard rehabilitation. The other group will receive the same rehabilitation plus extra practice with everyday walking tasks, such as changing speed, turning, and stepping over obstacles. Both groups will attend three supervised sessions per week for eight weeks.
Participants will be assessed before starting the program and again at weeks 4 and 8. The person who performs the assessments will be unaware of each participant's group assignment. The main outcome is balance during walking tasks at week 8. The study will also assess walking speed and distance, the ability to get up from a chair and move around, back and leg pain, and how back problems affect daily activities.
This is an assessor-blinded, parallel-group randomized controlled trial in adults with persistent walking or balance difficulties after lumbar decompression without fusion for lumbar spinal stenosis. Baseline assessments will take place 6 to 12 weeks after surgery, before randomization. Participants will be assigned in a 1:1 ratio to standard rehabilitation or standard rehabilitation plus task-specific gait training.
The additional training will be progressed according to each participant's ability to complete the walking tasks safely and without a marked increase in symptoms. The comparison will estimate the effect of adding the training program to standard rehabilitation, including the additional exercise time and therapist contact.
The primary analysis will compare Functional Gait Assessment (FGA) total scores at week 8 between groups, adjusting for baseline FGA scores. Weeks 4 and 8 are measured from the start of the rehabilitation program. Week 4 assessments are exploratory. Adverse events will be monitored and documented throughout the intervention period.
459 studies on the registry are indexed under Spinal Stenosis; 106 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 282 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Istanbul Medipol University Hospital is the lead sponsor of 367 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive approximately 40 minutes of supervised standard rehabilitation per session, three times per week for eight weeks. They will also receive the standard home exercise program.
Behavioral: Standard Rehabilitation
Participants will receive the same supervised standard rehabilitation and home exercise program as the active comparator group. Each supervised session will also include approximately 20 minutes of task-specific gait training, for a total of approximately 60 minutes per session, three times per week for eight weeks.
Behavioral: Standard Rehabilitation · Behavioral: Task-Specific Gait Training
The supervised program includes a warm-up, trunk control exercises, lower-limb strengthening, flexibility and mobility exercises, comfortable walking on a level and unobstructed surface, and a cool-down. Exercises are individualized according to postoperative restrictions, symptoms, and movement quality. Both groups receive the same home program, which takes approximately 15 to 20 minutes and is performed three days per week.
The additional supervised training includes starting and stopping, changing walking speed and step length, turning, side-stepping, and stepping over obstacles. Tasks progress from individual skills to courses that combine multiple walking tasks. Difficulty is adjusted according to each participant's ability to complete the tasks safely and without a marked increase in symptoms.
Functional Gait Assessment (FGA) Total Score at Week 8
The Functional Gait Assessment evaluates balance during 10 walking tasks. Each item is scored from 0 to 3, yielding a total score from 0 to 30. Higher scores indicate better walking balance. The primary analysis will compare week 8 scores between groups, adjusting for baseline FGA scores.
Time frame: Week 8 after the start of the rehabilitation program
Timed Up and Go (TUG) Test Time
Time in seconds to rise from a chair, walk 3 meters, turn, walk back, and sit down. The mean of two timed trials will be used. Shorter times indicate better functional mobility.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Comfortable Walking Speed on the 10-Meter Walk Test
Walking speed at a self-selected comfortable pace, measured in meters per second over the middle 10 meters of a 14-meter walkway. The mean speed from two timed trials will be used. Higher values indicate faster walking.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Fast Walking Speed on the 10-Meter Walk Test
Walking speed at the fastest safe pace without running, measured in meters per second over the middle 10 meters of a 14-meter walkway. The mean speed from two timed trials will be used. Higher values indicate faster walking.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Six-Minute Walk Test Distance
Total distance walked in six minutes on a level 30-meter corridor, recorded in meters. The clock continues during rest breaks. Greater distance indicates better walking capacity.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Five Times Sit-to-Stand Test Time
Time in seconds from the start command to reaching full standing on the fifth repetition. The mean of two timed trials will be used. Shorter times indicate better sit-to-stand performance.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Oswestry Disability Index (ODI) Score
A 10-section questionnaire assessing how low back problems affect daily activities. Each section is scored from 0 to 5, and the total is expressed as a percentage from 0% to 100%. Higher scores indicate greater disability.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Low Back Pain Intensity on the Numeric Rating Scale (NRS)
Participant-reported average low back pain intensity over the past 24 hours, rated from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Leg Pain Intensity on the Numeric Rating Scale (NRS)
Participant-reported average leg pain intensity over the past 24 hours, rated from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Time frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Functional Gait Assessment (FGA) Total Score at Week 4
Exploratory assessment of walking balance using the 10-item Functional Gait Assessment. Total scores range from 0 to 30, with higher scores indicating better walking balance.
Time frame: Week 4 after the start of the rehabilitation program
No study locations are listed for this record.
Plan to share: No — There is no current plan to share individual participant data. Any future request would be considered on a case-by-case basis, subject to applicable ethics, institutional, and data protection requirements.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 2 months is below that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Medipol University Hospital →