StrokeNCT05163444
Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
A study testing Gait analysis with rolling cane and Gait analysis with quadripod cane in people with Stroke and Hemiplegic Gait, run by University of Liege at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegic Gait
- What is being tested?
- Gait analysis with rolling cane and Gait analysis with quadripod cane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- 26 Feb 2022to 31 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment
- acute orthopedic impairment
- other pathologies affecting walking (Parkinson's disease, severe polyneuropathy,...)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
CHUOA
Esneux, Liege, 4130
Berengere Maillard, Dr, bmaillard@chuliege.be
- Recruiting
CNRF
Tinlot, Liege, 4557
Berengere Maillard, Dr, bmaillard@chuliege.be
About this study
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.
Read the 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.
- Conditions
- Stroke, Hemiplegic Gait
- Being tested
- Gait analysis with rolling cane, Gait analysis with quadripod cane
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait analysis with rolling caneDevice
6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes.
Gait analysis with quadripod caneDevice
6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes.
| Study group | Role | What they receive |
|---|---|---|
| Rolling can | Experimental | Gait analysis with rolling cane Receives: Device: Gait analysis with rolling cane |
| Quadripod can | Active comparator | Gait analysis with quadripod cane Receives: Device: Gait analysis with quadripod cane |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters walking test at fast speed
Calculate the walking speed
Measured: 2 days
Secondary outcomes (1)
6 minutes walking test at spontaneous speed
Spatio-temporals factors analysis (symmetry, time of unipodal/bipodal stance station,...)
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 posted20 Dec 2021
- Study start26 Feb 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical trial, randomized, crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maillard Berengere, University of Liege
- Investigators
- Berengere Maillard, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163444
- Sponsor's protocol ID
- Liege Hospital Ethic Comittee
- Status last verified
- May 2022
- First submitted
- 6 Dec 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis of Hemiparetics Adults Patients With Quadripod Cane and Rolling Cane
- ClinicalTrials.gov ID
- NCT05163444
- Acronym / sponsor ID
- Liege Hospital Ethic Comittee
- Conditions
- Stroke, Hemiplegic Gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 20 Dec 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical trial, randomized, crossover
| Arm | Type | Receives |
|---|---|---|
| Rolling can | Experimental | Device: Gait analysis with rolling caneGait analysis with rolling cane |
| Quadripod can | Active comparator | Device: Gait analysis with quadripod caneGait analysis with quadripod cane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- cognitive impairment
- acute orthopedic impairment
- other pathologies affecting walking (Parkinson's disease, severe polyneuropathy,...)
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 |
|---|---|---|
| Gait analysis with rolling cane6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes. | Device | Rolling can |
| Gait analysis with quadripod cane6 minutes walking test 10 meters walking test Before this experimentation, we will fix wearables sensors on the shoes. | Device | Quadripod can |
Primary outcome
10 meters walking test at fast speed
Time frame: 2 days
Calculate the walking speed
1 secondary outcome
6 minutes walking test at spontaneous speed
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Berengere Maillard principal investigator
University of Liege
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait analysis with rolling cane and Gait analysis with quadripod cane in people with Stroke and Hemiplegic Gait, run by University of Liege at 2 sites 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berengere Maillard (+32 4 366 82 41, bmaillard@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meters walking test at fast 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 24 May 2022.