- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250753
Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis
May 7, 2026 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
The objective is to observe the evolution of walking parameters during the surgery process and find which of all calculated walking parameters represent the best indicators of functional disabilities and postoperative recovery for patient with lumbar spinal stenosis.
Study Overview
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Trois-Rivières, Quebec, Canada, G9A 5H7
- Université du Québec à Trois-Rivières
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients older than 18 years old with lumbar spinal stensois
Description
Inclusion Criteria:
- Patients with lumbar spinal stenosis
- Presenting neurogenic claudication
- Waiting for a surgery (laminectomy, laminotomy, fusion)
Exclusion Criteria:
- Symptomatic hip or knee osteoarthritis
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with lumbar spinal stenosis
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30 meters walking task (15 meters round trip) following by a rest period of 2 minutes.
Participants are invited to perform the 30 meters walking task twice.
Inertial sensors are put on each participant foot.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)
Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery
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pain, function and satisfaction related to lumbar spinal stenosis.
Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome.
The total score is composed of the three subscales and range from 18 to 79.
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Baseline, 6 weeks post-surgery, 6 months post-surgery
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Change from baseline Quality of life (EuroQol - 5D)
Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery
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Quality of life related to mobility, self-care, usual activities, pain and discomfort, anxiety and depression.
Each category has a score ranging from 1 to 3 and higher values indicate a worst outcome.
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Baseline, 6 weeks post-surgery, 6 months post-surgery
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Change from baseline International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery
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physical activity habits.
IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity
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Baseline, 6 weeks post-surgery, 6 months post-surgery
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Change from baseline Walking time
Time Frame: Baseline, 6 weeks post-surgery
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Time participants take to do the walking task in seconds
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Baseline, 6 weeks post-surgery
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Change from baseline Walking speed
Time Frame: Baseline, 6 weeks post-surgery
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the walking stride velocity (meter/second) is the mean speed of forward walking, calculated in meters per second
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Baseline, 6 weeks post-surgery
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Change from baseline Gait cycle
Time Frame: Baseline, 6 weeks post-surgery
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Gait cycle (% stance phase, % swing phase)
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Baseline, 6 weeks post-surgery
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Change from baseline Stride length
Time Frame: Baseline, 6 weeks post-surgery
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Stride Length [m] describes the distance between two successive footprints on the ground, from the heel of a foot to the heel of the same foot, one cycle after.
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Baseline, 6 weeks post-surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline Swing Width
Time Frame: Baseline, 6 weeks post-surgery
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Swing Width (m) is the maximal lateral excursion of the foot during swing phase.
It is the maximum lateral distance between the forward path and the real path of the foot.
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Baseline, 6 weeks post-surgery
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Change from baseline Minimal To Clearance
Time Frame: Baseline, 6 weeks post-surgery
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Min. Toe Clearance (meter) is the minimum height of the toes during swing phase.
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Baseline, 6 weeks post-surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
November 1, 2019
Primary Completion (Actual)
November 1, 2025
Study Completion (Actual)
December 30, 2025
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
January 30, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 7, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQTR-2019-claudication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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