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

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ClinicalTrials.gov Identifier: NCT04250753
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Descarreaux, Université du Québec à Trois-Rivières

Tracking Information
First Submitted Date January 29, 2020
First Posted Date January 31, 2020
Last Update Posted Date January 31, 2020
Actual Study Start Date November 1, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2020)
  • Change from baseline French-Canadian adaptation of Swiss Spinal Stenosis Questionnaires (FC-SSSQ) [ Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery ]
    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.
  • Change from baseline Quality of life (EuroQol - 5D) [ Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery ]
    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.
  • Change from baseline International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline, 6 weeks post-surgery, 6 months post-surgery ]
    physical activity habits. IPAQ score range from 1 to 3 where a score of 3 indicates a higher practice of physical activity
  • Change from baseline Walking time [ Time Frame: Baseline, 6 weeks post-surgery ]
    Time participants take to do the walking task in seconds
  • Change from baseline Walking speed [ Time Frame: Baseline, 6 weeks post-surgery ]
    the walking stride velocity (meter/second) is the mean speed of forward walking, calculated in meters per second
  • Change from baseline Gait cycle [ Time Frame: Baseline, 6 weeks post-surgery ]
    Gait cycle (% stance phase, % swing phase)
  • Change from baseline Stride length [ Time Frame: Baseline, 6 weeks post-surgery ]
    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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 30, 2020)
  • Change from baseline Swing Width [ Time Frame: Baseline, 6 weeks post-surgery ]
    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.
  • Change from baseline Minimal To Clearance [ Time Frame: Baseline, 6 weeks post-surgery ]
    Min. Toe Clearance (meter) is the minimum height of the toes during swing phase.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis: a Feasibility Study
Official Title Assessment of Gait Parameters and Their Impact on Postoperative Recovery in Patients With Lumbar Spinal Stenosis: a Feasibility Study
Brief Summary The first aim is to evaluate the integration's feasibility of a research project linked to the walking parameters into the clinical process pre and postoperative for patient with lumbar spinal stenosis who consult in neurosurgery. The second 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 8 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients older than 18 years old with lumbar spinal stensois
Condition Lumbar 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.
Study Groups/Cohorts Patients with lumbar spinal stenosis
Intervention: Other: Walking task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 30, 2020)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with lumbar spinal stenosis
  • Presenting neurogenic claudication
  • Waiting for a surgery (laminectomy, laminotomy, fusion)

Exclusion Criteria:

  • Symptomatic hip or knee osteoarthritis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Martin Descarreaux, PhD 819 376-5011 ext 3791 martin.descarreaux@uqtr.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04250753
Other Study ID Numbers UQTR-2019-claudication
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Martin Descarreaux, Université du Québec à Trois-Rivières
Study Sponsor Université du Québec à Trois-Rivières
Collaborators Not Provided
Investigators Not Provided
PRS Account Université du Québec à Trois-Rivières
Verification Date January 2020