AmputationNCT06994741
Gait Parameters in a Cohort of Patients Fitted With a Canadian Prosthesis: Contribution of Quantified Gait Analysis
An observational study of Amputation and Gait, Unsteady, run by Institut Robert Merle d'aubigné at 1 site in France.
Trial summary
The goal of this clinical trial is to learn about the biomechanics characterics of amputee with a canadian prothesis during gait. The main question to answer is : what are the main biomechanical characteristics and their statistical description. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Gait, Unsteady
- What is being tested?
- Quantitative movement analysis
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 1 Oct 2024
- Phase
- Observational
- 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
Study population: amputee with canadian prothesis
Who may be able to join
- with canadian prothesis
- presence of the gait analysis
Who cannot join
- major gait disorder due to another pathologie
- major gait disorder due to a wrong adapration of the prothesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study of Gait Parameters in a Cohort of Patients Fitted With a Canadian Prosthesis: Contribution of Quantified Gait Analysis
The goal of this clinical trial is to learn about the biomechanics characterics of amputee with a canadian prothesis during gait. The main question to answer is : what are the main biomechanical characteristics and their statistical description.
Participant had pass through a quantitative movement analysis during their classic reeducaiton and we are going to use these data.
- Conditions
- Amputation, Gait, Unsteady
- Being tested
- Quantitative movement analysis
- Keywords
- Canadian prothesis
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative movement analysisOther
During their reeducation, patient can go through an quantitative movement analysis. Inside a movement laboratory, we observe their gait with 5 passageways.
| Study group | Role | What they receive |
|---|---|---|
| Amputee with canadian prothesis | Not described Receives: Other: Quantitative movement analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
(m/s) with a motion laboratory - Vicon system with 8 cameras, Nexus 2.4 et Polygon 2.4
Measured: Day 1
Secondary outcomes (3)
Joint range of motion
(°) with a motion laboratory - Vicon system with 8 cameras, Nexus 2.4 et Polygon 2.4
Measured: Day 1
Force apply to the ground
(N/m2) with a motion laboratory and 2 forceplates AMTI - Vicon system with 8 cameras, Nexus 2.4 et Polygon 2.4
Measured: Day 1
Steplength
Measured: During the quantitative movement analysis - retrospective data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Robert Merle d'aubigné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994741
- Sponsor's protocol ID
- 2024 - RNIPH - 001
- Status last verified
- May 2025
- First submitted
- 15 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Gait Parameters in a Cohort of Patients Fitted With a Canadian Prosthesis: Contribution of Quantified Gait Analysis
- ClinicalTrials.gov ID
- NCT06994741
- Acronym / sponsor ID
- 2024 - RNIPH - 001
- Conditions
- Amputation, Gait, Unsteady
- Keywords
- Canadian prothesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut Robert Merle d'aubignéUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 May 2025 (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.
The goal of this clinical trial is to learn about the biomechanics characterics of amputee with a canadian prothesis during gait. The main question to answer is : what are the main biomechanical characteristics and their statistical description.
Participant had pass through a quantitative movement analysis during their classic reeducaiton and we are going to use these data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amputee with canadian prothesis | – | Other: Quantitative movement analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- amputee with canadian prothesis
Key inclusion criteria (2 listed)
- with canadian prothesis
- presence of the gait analysis
Key exclusion criteria (2 listed)
- major gait disorder due to another pathologie
- major gait disorder due to a wrong adapration of the prothesis
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 |
|---|---|---|
| Quantitative movement analysisDuring their reeducation, patient can go through an quantitative movement analysis. Inside a movement laboratory, we observe their gait with 5 passageways. | Other | Amputee with canadian prothesis |
Primary outcome
Walking speed
Time frame: Day 1
(m/s) with a motion laboratory - Vicon system with 8 cameras, Nexus 2.4 et Polygon 2.4
3 secondary outcomes
Joint range of motion
Time frame: Day 1
Force apply to the ground
Time frame: Day 1
Steplength
Time frame: During the quantitative movement analysis - retrospective data
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Gait, Unsteady, run by Institut Robert Merle d'aubigné at 1 site in France.
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 29 May 2025. 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 France. 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?
Walking speed (time frame: Day 1). 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 29 May 2025.