NCT02279069

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

October 28, 2014

Last Update Submit

October 22, 2019

Conditions

Stroke

Keywords

strokewalkingrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 10 meters walking test at spontaneous speed

    2 days

Secondary Outcomes (5)

  • 10 meters walking test at fast speed

    2 days

  • 6 minutes walking test

    2 days

  • Borg scale for perceived exertion

    2 days

  • Visual analogic scale for personal satisfaction

    2 days

  • Energy cost

    2 days

Study Arms (2)

4-point canne

ACTIVE COMPARATOR

Stroke patients walk with 4-point canne

Device: 4-roll canne

4-roll canne

EXPERIMENTAL

Stroke patients walk with 4-roll canne

Device: 4-roll canne

Interventions

4-roll canneDEVICE
4-point canne4-roll canne

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post stroke patient
  • able to walk 10 meters

You may not qualify if:

  • cognitive impairment limiting walking capacities
  • need support when walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deltombe Thierry

Yvoir, 5530, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thierry Deltombe, MD

    CHU Dinant Godinne / UcL Namur

    PRINCIPAL INVESTIGATOR

  • Geoffroy Dellicour, PT

    Centre Neurologique William Lennox Ottignies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur Clinique

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 30, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

BE(1)