Stroke4rollNCT02279069
4-point vs 4-roll Canne as Walking Aids After Stroke
A study testing 4-roll canne in people with Stroke, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- 4-roll canne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post stroke patient
- able to walk 10 meters
Who cannot join
- cognitive impairment limiting walking capacities
- need support when walking
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Stroke
- Being tested
- 4-roll canne
- Keywords
- stroke, walking, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-roll canneDevice
| Study group | Role | What they receive |
|---|---|---|
| 4-point canne | Active comparator | Stroke patients walk with 4-point canne Receives: Device: 4-roll canne |
| 4-roll canne | Experimental | Stroke patients walk with 4-roll canne Receives: Device: 4-roll canne |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters walking test at spontaneous speed
Measured: 2 days
Secondary outcomes (5)
10 meters walking test at fast speed
Measured: 2 days
6 minutes walking test
Measured: 2 days
Borg scale for perceived exertion
Measured: 2 days
Visual analogic scale for personal satisfaction
Measured: 2 days
Energy cost
Extrapolated from heart rate while walking
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deltombe Thierry, University Hospital of Mont-Godinne
- Investigators
- Thierry Deltombe, MD, Principal investigator, CHU Dinant Godinne / UcL NamurGeoffroy Dellicour, PT, Principal investigator, Centre Neurologique William Lennox Ottignies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279069
- Sponsor's protocol ID
- MG-4roll-53/2014
- Acronym
- 4roll
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2014
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02279069
- Acronym / sponsor ID
- 4roll / MG-4roll-53/2014
- Conditions
- Stroke
- Keywords
- stroke, walking, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-point canne | Active comparator | Device: 4-roll canneStroke patients walk with 4-point canne |
| 4-roll canne | Experimental | Device: 4-roll canneStroke patients walk with 4-roll canne |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post stroke patient
- able to walk 10 meters
Key exclusion criteria (2 listed)
- cognitive impairment limiting walking capacities
- need support when walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4-roll canne | Device | 4-point canne, 4-roll canne |
Primary outcome
10 meters walking test at spontaneous speed
Time frame: 2 days
5 secondary outcomes
10 meters walking test at fast speed
Time frame: 2 days
6 minutes walking test
Time frame: 2 days
Borg scale for perceived exertion
Time frame: 2 days
Visual analogic scale for personal satisfaction
Time frame: 2 days
Energy cost
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Deltombe, MD principal investigator
CHU Dinant Godinne / UcL Namur
Geoffroy Dellicour, PT principal investigator
Centre Neurologique William Lennox Ottignies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-roll canne in people with Stroke, run by University Hospital of Mont-Godinne at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meters walking test at spontaneous speed (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.