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Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis

Primary Purpose

Spinal Stenosis

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Exercises and education

Education alone

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring Spinal Stenosis, Neurogenic claudication, Walking capacity, Exercises, Education, gait pattern characteristics

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

being at least 50 years old
having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
having NC associated with LSS
being able to speak and understand French
being willing to attend 3 intervention sessions per week
with a duration of signs and symptoms of at least 3 months
(7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
being able to provide informed written consent.

Exclusion Criteria:

congenital LSS,
symptomatic osteoarthritis (hip or knee) causing limited walking capacity
neurological disease affecting walking capacity such as Parkinson
uncontrolled diabetes
heart failure
intermittent claudication of vascular origin
impaired cognitive capacity
back or lower extremities surgery in the past 3 months

Sites / Locations

Université du Québec à Trois-RivièresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

Intervention group will received education and a specific rehabilitation program (exercises).

Control group will received education alone.

Outcomes

Primary Outcome Measures

Change from baseline in walking capacity

Walking capacity measure with the Self-Paced Walking Test (time)

Secondary Outcome Measures

Change from baseline in leg and back pain intensity

Leg and back pain intensity will be independently assessed using a 11-point numerical rating scale (from 0 to 10 points). Higher score indicates higher pain.

Change from baseline in lumbar spinal stenosis related disabiltity

Lumbar spinal stenosis related disability is measured with the French-Canadian version of the Swiss Spinal Stenosis Questionnaire. 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.

Changes from baseline in self-efficacy

Measured with Self-efficacy measured with the French-Canadian Chronic Pain Self-Efficacy Scale. Each question is rated on a numerical scale (from 1 to 10). Total is calculated using the mean of the 33-items scores and ranges from 1 to 10 with a higher score indicate higher self-efficacy.

Change from baseline in anxiety and depression

Measured with the French-Canadian adaptation of the Hospital Anxiety and Depression Scale. Total score range from 0 to 21 with higher score indicating symptoms of anxiety and/or depression.

Change from baseline in physical activity level

Physical activity level assessed with the [Physical Activity Questionnaire for the Elderly]. The questionnaire allows to place participants into one of the 3 categories (low, moderate or high physical activity level). Physical activity level is measured in time per day.

Patient's global impression of change

Global impression of change will be measured using a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point.

Change from baseline in biomechanical parameters of gait

Spatio-temporal parameters of gait measured with wearable inertial sensors (velocity (m/s))

Change from baseline in biomechanical parameters of gait

Spatio-temporal parameters of gait measured with wearable inertial sensors measured in meters (stride length, swing witdh, toe clearance)

Change from baseline in biomechanical parameters of gait

Spatio-temporal parameters of gait measured with wearable inertial sensors measured in % (walking phases, assymetry, variability)

Change from baseline in lower extremity physical function and balance

Lower extremity physical function and balance measured with the Short Physical Performance Battery. Total score ranges from 0 to 12 with higher score indicating a better lower extremity physical function and balance.

Full Information

NCT ID

NCT05513326

First Posted

July 7, 2022

Last Updated

May 8, 2023

Sponsor

Université du Québec à Trois-Rivières

1. Study Identification

Unique Protocol Identification Number

NCT05513326

Brief Title

Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis

Official Title

Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients With Lumbar Spinal Stenosis With Neurogenic Claudication

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2023 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Université du Québec à Trois-Rivières

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC. The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Stenosis

Keywords

Spinal Stenosis, Neurogenic claudication, Walking capacity, Exercises, Education, gait pattern characteristics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Intervention group will received education and a specific rehabilitation program (exercises).

Arm Title

Control Group

Arm Type

Other

Arm Description

Control group will received education alone.

Intervention Type

Other

Intervention Name(s)

Exercises and education

Intervention Description

Exercises: 3 training sessions per week that will last for 30 minutes. Sessions will start with 5 minutes of activation (walking on a treadmill or cycling). Then, participants will be asked to complete 5 exercises targeting lower limb strengthening (time: 18 minutes) followed by 2 exercises designed to improve balance and 3 stretching exercises for the lower limb (time: 7 minutes). Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.

Intervention Type

Other

Intervention Name(s)

Education alone

Intervention Description

Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.

Primary Outcome Measure Information:

Title

Change from baseline in walking capacity

Description

Walking capacity measure with the Self-Paced Walking Test (time)

Time Frame

Baseline, week 2, week 4, week 6, week 12

Secondary Outcome Measure Information:

Title

Change from baseline in leg and back pain intensity

Description

Leg and back pain intensity will be independently assessed using a 11-point numerical rating scale (from 0 to 10 points). Higher score indicates higher pain.

Time Frame

Baseline, week 2, week 4, week 6, week 12

Title

Change from baseline in lumbar spinal stenosis related disabiltity

Description

Time Frame

Baseline, week 6, week 12

Title

Changes from baseline in self-efficacy

Description

Time Frame

Baseline, week 6, week 12

Title

Change from baseline in anxiety and depression

Description

Measured with the French-Canadian adaptation of the Hospital Anxiety and Depression Scale. Total score range from 0 to 21 with higher score indicating symptoms of anxiety and/or depression.

Time Frame

Baseline, week 6, week 12

Title

Change from baseline in physical activity level

Description

Time Frame

Baseline, week 6, week 12

Title

Patient's global impression of change

Description

Global impression of change will be measured using a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point.

Time Frame

changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)

Title

Change from baseline in biomechanical parameters of gait

Description

Spatio-temporal parameters of gait measured with wearable inertial sensors (velocity (m/s))

Time Frame

Baseline, week 2, week 4, week 6, week 12

Title

Change from baseline in biomechanical parameters of gait

Description

Spatio-temporal parameters of gait measured with wearable inertial sensors measured in meters (stride length, swing witdh, toe clearance)

Time Frame

Baseline, week 2, week 4, week 6, week 12

Title

Change from baseline in biomechanical parameters of gait

Description

Spatio-temporal parameters of gait measured with wearable inertial sensors measured in % (walking phases, assymetry, variability)

Time Frame

Baseline, week 2, week 4, week 6, week 12

Title

Change from baseline in lower extremity physical function and balance

Description

Time Frame

Baseline, week 6, week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: being at least 50 years old having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging having NC associated with LSS being able to speak and understand French being willing to attend 3 intervention sessions per week with a duration of signs and symptoms of at least 3 months (7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes being able to provide informed written consent. Exclusion Criteria: congenital LSS, symptomatic osteoarthritis (hip or knee) causing limited walking capacity neurological disease affecting walking capacity such as Parkinson uncontrolled diabetes heart failure intermittent claudication of vascular origin impaired cognitive capacity back or lower extremities surgery in the past 3 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mariève Houle, PhD(c)

Phone

819 376-5011

Ext

3969

marieve.houle@uqtr.ca

Facility Information:

Facility Name

Université du Québec à Trois-Rivières

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8Z 4M3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariève Houle, PhD (c)

Phone

819 376-5011

Ext

3969

marieve.houle@uqtr.ca

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis

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