Walking Training After Lumbar Decompression Surgery

November 9, 2026 updated by: salih tan, Istanbul Medipol University Hospital

Effectiveness of Task-Specific Gait Training After Lumbar Decompression: An Assessor-Blinded Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30-65 years, inclusive.
  • Primary lumbar decompression without fusion for lumbar spinal stenosis.
  • Baseline assessment 6-12 weeks after surgery.
  • Surgeon clearance for exercise and physical performance testing.
  • Self-reported walking difficulty and at least one walking-task limitation documented at screening.
  • Able to walk at least 10 meters without another person's physical assistance, with or without a walking aid.
  • Able to understand test instructions.
  • Agrees to the 8-week program and all 3 assessments.
  • Provides written informed consent.

Exclusion Criteria:

  • Spinal fusion or instrumentation at decompression, or revision surgery in the same lumbar region.
  • Active wound infection, ongoing cerebrospinal fluid leak, or a postoperative complication preventing exercise.
  • Progressive neurological deficit, signs of cauda equina syndrome, or need for surgical reassessment.
  • Neurological condition that independently affects walking, such as stroke, Parkinson disease, multiple sclerosis, or significant peripheral neuropathy.
  • Advanced hip or knee disease, recent lower-limb fracture, or major lower-limb surgery that substantially affects walking.
  • Uncontrolled vestibular disorder or severe uncorrected visual impairment.
  • Cardiovascular, pulmonary, or systemic disease that a physician considers a contraindication to exercise or testing.
  • Active malignancy, spinal infection, or acute vertebral fracture.
  • Concurrent structured gait and balance rehabilitation.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Rehabilitation

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

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.
Experimental: Standard Rehabilitation Plus Task-Specific Gait Training

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

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.

Behavioral: Task-Specific Gait Training

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Gait Assessment (FGA) Total Score at Week 8
Time Frame: Week 8 after the start of the rehabilitation program

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.
Week 8 after the start of the rehabilitation program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG) Test Time
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
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
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
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
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Six-Minute Walk Test Distance
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Five Times Sit-to-Stand Test Time
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
Oswestry Disability Index (ODI) Score
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
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)
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
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)
Time Frame: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

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.
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Gait Assessment (FGA) Total Score at Week 4
Time Frame: Week 4 after the start of the rehabilitation program

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.
Week 4 after the start of the rehabilitation program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMU-LD-GAIT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings