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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
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

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

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

First Posted
December 6, 2021
Last Updated
May 17, 2022
Sponsor
University of Liege
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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

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Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane

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