4-point vs 4-roll Canne as Walking Aids After Stroke (4roll)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
4-roll canne
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, walking, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- post stroke patient
- able to walk 10 meters
Exclusion Criteria:
- cognitive impairment limiting walking capacities
- need support when walking
Sites / Locations
- Deltombe Thierry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
4-point canne
4-roll canne
Arm Description
Stroke patients walk with 4-point canne
Stroke patients walk with 4-roll canne
Outcomes
Primary Outcome Measures
10 meters walking test at spontaneous speed
Secondary Outcome Measures
10 meters walking test at fast speed
6 minutes walking test
Borg scale for perceived exertion
Visual analogic scale for personal satisfaction
Energy cost
Extrapolated from heart rate while walking
Full Information
NCT ID
NCT02279069
First Posted
October 28, 2014
Last Updated
October 22, 2019
Sponsor
University Hospital of Mont-Godinne
1. Study Identification
Unique Protocol Identification Number
NCT02279069
Brief Title
4-point vs 4-roll Canne as Walking Aids After Stroke
Acronym
4roll
Official Title
Comparison Between Classical 4-point Canne and 4-roll Canne on Gait Parameters (Gait Speed and Energy Cost) as Walking Aids After Stroke. A Multicentric Randomized Controled Cross-over Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Mont-Godinne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stroke patients frequently necessitate walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.
The aim of our study is to compare gait parameters (gait speed and energy cost) with a classical 4-point canne and with 4-roll canne.
Detailed Description
Stroke patients frequently need walking aids such as 4-point canne. However, the 4-point canne has to be lifted by the patient which limited gait speed. The adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground.
OBJECTIVE To compare the gait parameters with a 4-point canne and with a 4-roll canne METHODS The investigators will recruited stroke patients who necessitate 4 point-canne as walking aids. A 10 meters walking test, a 6 minutes walking test, an estimated energy cost and a patient's satisfaction will be monitored with a 4-point canne (day 1) and with a 4-roll canne (day 2) in a cross-over study. The first tested device will be randomized.
PERSPECTIVE The investigators hope to demonstrate that a 4-roll canne makes possible to walk faster in a safe way after stroke
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, walking, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4-point canne
Arm Type
Active Comparator
Arm Description
Stroke patients walk with 4-point canne
Arm Title
4-roll canne
Arm Type
Experimental
Arm Description
Stroke patients walk with 4-roll canne
Intervention Type
Device
Intervention Name(s)
4-roll canne
Primary Outcome Measure Information:
Title
10 meters walking test at spontaneous speed
Time Frame
2 days
Secondary Outcome Measure Information:
Title
10 meters walking test at fast speed
Time Frame
2 days
Title
6 minutes walking test
Time Frame
2 days
Title
Borg scale for perceived exertion
Time Frame
2 days
Title
Visual analogic scale for personal satisfaction
Time Frame
2 days
Title
Energy cost
Description
Extrapolated from heart rate while walking
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post stroke patient
able to walk 10 meters
Exclusion Criteria:
cognitive impairment limiting walking capacities
need support when walking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Deltombe, MD
Organizational Affiliation
CHU Dinant Godinne / UcL Namur
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geoffroy Dellicour, PT
Organizational Affiliation
Centre Neurologique William Lennox Ottignies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deltombe Thierry
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
4-point vs 4-roll Canne as Walking Aids After Stroke
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