Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
Primary Purpose
Stroke, Hemiplegic Gait
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Gait analysis with rolling cane
Gait analysis with quadripod cane
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Hemiparesis following a stroke
- Be able to walk with a quadripod cane independently
- Be able to walk with the rolling cane independently
- Be able to follow instructions
Exclusion Criteria:
- cognitive impairment
- acute orthopedic impairment
- other pathologies affecting walking (Parkinson's disease, severe polyneuropathy,...)
Sites / Locations
- CHUOARecruiting
- CNRFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rolling can
Quadripod can
Arm Description
Gait analysis with rolling cane
Gait analysis with quadripod cane
Outcomes
Primary Outcome Measures
10 meters walking test at fast speed
Calculate the walking speed
Secondary Outcome Measures
6 minutes walking test at spontaneous speed
Spatio-temporals factors analysis (symmetry, time of unipodal/bipodal stance station,...)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05163444
Brief Title
Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
Official Title
Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
After stroke, a lot of patients present an hemiparesis and gait disorders. They need walking aids like quadripod cane or rolling cane.
The quadripod cane confers a great stability but implies a walk in 3 times, thus consume more energy. The pause time necessary for the displacement (uplift) of the cane disappear with the Wheeleo.
The investigators will study many spatio-temporal parameters to determine which one allows to decrease the walking speed.
Detailed Description
Hemiparesis affects 65% of stroke patients and cause gait disorders. During rehabilitation, patients often need technical aids to the the return to walk.
For example, they can use the quadripod cane and the rolling cane, called Wheeleo. Regarding the first one, as its name indicate, there are 4 feet while the other model has 4 wheels.
Deltombe and al. proved that the walking speed is higher with a rolling cane. The investigators will recruited stroke patients and study many spatio-temporal parameters with a gait analysis system, when participants are walking with the two walking aids.
Participants will achieve 6 minutes walking test and a 10 meters walking test, with a wearable inertial systems on their shoes.
The investigators wish to reveal which spatio-temporal parameters most influence walking speed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegic Gait
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Clinical trial, randomized, crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rolling can
Arm Type
Experimental
Arm Description
Gait analysis with rolling cane
Arm Title
Quadripod can
Arm Type
Active Comparator
Arm Description
Gait analysis with quadripod cane
Intervention Type
Device
Intervention Name(s)
Gait analysis with rolling cane
Intervention Description
6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes.
Intervention Type
Device
Intervention Name(s)
Gait analysis with quadripod cane
Intervention Description
6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes.
Primary Outcome Measure Information:
Title
10 meters walking test at fast speed
Description
Calculate the walking speed
Time Frame
2 days
Secondary Outcome Measure Information:
Title
6 minutes walking test at spontaneous speed
Description
Spatio-temporals factors analysis (symmetry, time of unipodal/bipodal stance station,...)
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Hemiparesis following a stroke
Be able to walk with a quadripod cane independently
Be able to walk with the rolling cane independently
Be able to follow instructions
Exclusion Criteria:
cognitive impairment
acute orthopedic impairment
other pathologies affecting walking (Parkinson's disease, severe polyneuropathy,...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berengere Maillard
Phone
+32 4 366 82 41
Email
bmaillard@chuliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-françois KAUX
Phone
+32 4 366 82 41
Email
jfkaux@chuliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berengere Maillard
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUOA
City
Esneux
State/Province
Liege
ZIP/Postal Code
4130
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berengere Maillard, Dr
Email
bmaillard@chuliege.be
Facility Name
CNRF
City
Tinlot
State/Province
Liege
ZIP/Postal Code
4557
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berengere Maillard, Dr
Email
bmaillard@chuliege.be
12. IPD Sharing Statement
Learn more about this trial
Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
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