NCT05163444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 26, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

December 6, 2021

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 10 meters walking test at fast speed

    Calculate the walking speed

    2 days

Secondary Outcomes (1)

  • 6 minutes walking test at spontaneous speed

    2 days

Study Arms (2)

Rolling can

EXPERIMENTAL

Gait analysis with rolling cane

Device: Gait analysis with rolling cane

Quadripod can

ACTIVE COMPARATOR

Gait analysis with quadripod cane

Device: Gait analysis with quadripod cane

Interventions

6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes.

Rolling can

6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes.

Quadripod can

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • cognitive impairment
  • acute orthopedic impairment
  • other pathologies affecting walking (Parkinson's disease, severe polyneuropathy,...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHUOA

Esneux, Liege, 4130, Belgium

RECRUITING

CNRF

Tinlot, Liege, 4557, Belgium

RECRUITING

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Berengere Maillard

    University of Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berengere Maillard

CONTACT

Jean-françois KAUX

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Clinical trial, randomized, crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 20, 2021

Study Start

February 26, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations