Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250753
• Other study ID #: UQTR-2019-claudication
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Université du Québec à Trois-Rivières
• Contact: Martin Descarreaux, PhD
• Phone: 819 376-5011
• Email: martin.descarreaux[@]uqtr.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with lumbar spinal stenosis

• Presenting neurogenic claudication

• Waiting for a surgery (laminectomy, laminotomy, fusion)

Exclusion Criteria:

• Symptomatic hip or knee osteoarthritis

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Other:
• Walking task
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.

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	Change from baseline 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.	Baseline, 6 weeks post-surgery, 6 months post-surgery
Primary	Change from baseline Quality of life (EuroQol - 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.	Baseline, 6 weeks post-surgery, 6 months post-surgery
Primary	Change from baseline 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	Baseline, 6 weeks post-surgery, 6 months post-surgery
Primary	Change from baseline Walking time	Time participants take to do the walking task in seconds	Baseline, 6 weeks post-surgery
Primary	Change from baseline Walking speed	the walking stride velocity (meter/second) is the mean speed of forward walking, calculated in meters per second	Baseline, 6 weeks post-surgery
Primary	Change from baseline Gait cycle	Gait cycle (% stance phase, % swing phase)	Baseline, 6 weeks post-surgery
Primary	Change from baseline Stride length	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.	Baseline, 6 weeks post-surgery
Secondary	Change from baseline Swing Width	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.	Baseline, 6 weeks post-surgery
Secondary	Change from baseline Minimal To Clearance	Min. Toe Clearance (meter) is the minimum height of the toes during swing phase.	Baseline, 6 weeks post-surgery