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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04795284
Other study ID # UQTR_gaitup_2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 9, 2020
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source Université du Québec à Trois-Rivières
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design


Locations

Country Name City State
Canada Université du Québec à Trois-Rivières Trois-Rivieres Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary biomechanical walking parameters (gait cycle, stride length, walking time, walking speed, swing width, minimal toe clearance) 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
Primary Quality of life (Euro-Qol - 5D) 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)
Primary International Physical Activity Questionnaire (IPAQ) 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 French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ) 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
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