- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04795284
Biomechanical Parameters of Gait in Patients with Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
March 24, 2025 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières
The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
135
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
-
-
Quebec
-
Trois-Rivieres, Quebec, Canada, G9A 5H7
- Université du Québec à Trois-Rivières
-
-
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
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Group 1: Patients with a symptomatic lumbar spinal stenosis Group 2: Healthy elderly from the community
Description
Inclusion Criteria:
Patients with lumbar spinal stenosis
- Having a diagnosis of lumbar spinal stenosis (at least 1 level)
- Having neurologic claudication due to the lumbar spinal stenosis
Healthy elderly
- Being over 50 years old of age
- No back or leg pain during walking
Exclusion Criteria:
- Symptomatic hip or knee Ostearthritis
- Not able to give their free consent
- Being in a wheelchair (not able to walk 30 meters)
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 |
|---|
|
Patients with symptomatic lumbar spinal stenosis
30-meter walking task (15 meters round trip) following by a rest period of 2 minutes.
Participants are invited to perform the 30-meter walking task twice.
Inertial sensors are put on each participant foot.
|
|
Healthy elderly
30-meter walking task (15 meters round trip) following by a rest period of 2 minutes.
Participants are invited to perform the 30-meter walking task twice.
Inertial sensors are put on each participant foot.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance)
Time Frame: During the 30-meter walking test
|
Gait cycle = % stance phase, % swing phase / Stride length = describes the distance between two successive footprints on the ground / walking time = time to complete the 30-meters walking test in seconds / walking speed = walking stride velocity measured in meter/second / swing width = the maximal lateral excursion of the foot during the swing phase / minimal toe clearance = minimum height of the toes during the swing phase (in meter)
|
During the 30-meter walking test
|
|
Quality of life (Euro-Qol - 5D)
Time Frame: One time (before the completion of the 30-meter walking test)
|
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.
|
One time (before the completion of the 30-meter walking test)
|
|
International Physical Activity Questionnaire (IPAQ)
Time Frame: One time (before the completion of the 30-meter walking test)
|
Physical activity habits.
IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity
|
One time (before the completion of the 30-meter walking test)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ)
Time Frame: One time (before the completion of the 30-meter walking test) - Only for patients with lumbar spinal stenosis
|
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.
|
One time (before the completion of the 30-meter walking test) - Only for patients with lumbar spinal stenosis
|
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)
September 9, 2020
Primary Completion (Actual)
December 30, 2024
Study Completion (Actual)
December 30, 2024
Study Registration Dates
First Submitted
March 8, 2021
First Submitted That Met QC Criteria
March 10, 2021
First Posted (Actual)
March 12, 2021
Study Record Updates
Last Update Posted (Actual)
March 28, 2025
Last Update Submitted That Met QC Criteria
March 24, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UQTR_gaitup_2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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