Lower Limb AmputationPROTEORNCT03260530
Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis
An observational study of Lower Limb Amputation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Locomotor evaluation and Questionnaires
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to 7 Sep 2023
- 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: patients attending routine consultations for a prosthesis
Who may be able to join
- Patients able to understand simple instructions, the fitting instructions and to provide informed consent
- Man or woman aged > 18 years)
- Lower-limb amputee, transtibial or transfemoral amputation
Who cannot join
- Adult under guardianship
- Subject without national insurance cover
- Pregnant or breast-feeding women
- Patients with hip desarticulation
- Subjects presenting severe associated diseases affecting gait
Trial locations and contacts
1 site in 1 country.
About this study
It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. This justifies a quantitative approach to the locomotor abilities of these patients, with regard to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical parameters (quantified analysis of movement), so as to measure the real impact of the proposed prosthesis technology, as a complement to classical qualitative approaches.
In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC 1432), and the company PROTEOR established a research partnership aiming to:
Read more
- Refine the indications for the prescription of new products, by ensuring that they correspond to the profiles of the patients concerned and their true needs,
- Study the underlying adaptive mechanisms, and establish new recommendations for their use, depending on the profiles of the users,
- And ultimately, better evaluate, in a more rigorous and systematic manner, the prostheses available on the market.
The research protocol presented in this document aims to provide a framework for part of the explorations that will be conducted in the context of this partnership. Lower-limb amputees who will be evaluated in this research will wear these prostheses (foot and/or knee prostheses), which bear the CE logo, and thus present all of the safety and performance conditions required for their use by these patients (prostheses destined for usual prescriptions), the objective of the study was not to evaluate the prostheses as such, but to explore and quantify the impact of these prostheses and their eventual modifications on the locomotor abilities of the patients concerned.
The investigations will be conducted using non-invasive evaluation tools available on the PIT platform, with no modification in the usual management of these voluntary patients.
- Conditions
- Lower Limb Amputation
- Being tested
- Locomotor evaluation, Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotor evaluationOther
collection of parameters associated with walking and balance in patients with their usual prosthesis and then equipped with the new prosthesis
QuestionnairesOther
Houghton's scale, PPA-LCI, ABC, QEP, SF-12, SAT-PRO, ESAT
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start5 May 2017
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260530
- Sponsor's protocol ID
- CASILLAS PROTEOR 2016
- Acronym
- PROTEOR
- Status last verified
- Jun 2024
- First submitted
- 22 Aug 2017
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis
- ClinicalTrials.gov ID
- NCT03260530
- Acronym / sponsor ID
- PROTEOR / CASILLAS PROTEOR 2016
- Conditions
- Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 24 Aug 2017 (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.
It appears necessary to confront the reality of the contribution of technological progress in the creation of prostheses with the specific features of lower limb amputees. These contributions must be clearly identified in their different functional dimensions. This justifies a quantitative approach to the locomotor abilities of these patients, with regard to bioenergy parameters (consumption of oxygen while walking) and motor biomechanical parameters (quantified analysis of movement), so as to measure the real impact of the proposed prosthesis technology, as a complement to classical qualitative approaches.
In this context, Dijon CHU, thanks to its Technological Investigation Platform (PIT, CIC 1432), and the company PROTEOR established a research partnership aiming to:
- Refine the indications for the prescription of new products, by ensuring that they correspond to the profiles of the patients concerned and their true needs,
- Study the underlying adaptive mechanisms, and establish new recommendations for their use, depending on the profiles of the users,
- And ultimately, better evaluate, in a more rigorous and systematic manner, the prostheses available on the market.
The research protocol presented in this document aims to provide a framework for part of the explorations that will be conducted in the context of this partnership. Lower-limb amputees who will be evaluated in this research will wear these prostheses (foot and/or knee prostheses), which bear the CE logo, and thus present all of the safety and performance conditions required for their use by these patients (prostheses destined for usual prescriptions), the objective of the study was not to evaluate the prostheses as such, but to explore and quantify the impact of these prostheses and their eventual modifications on the locomotor abilities of the patients concerned.
The investigations will be conducted using non-invasive evaluation tools available on the PIT platform, with no modification in the usual management of these voluntary patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients attending routine consultations for a prosthesis
Key inclusion criteria (3 listed)
- Patients able to understand simple instructions, the fitting instructions and to provide informed consent
- Man or woman aged > 18 years)
- Lower-limb amputee, transtibial or transfemoral amputation
Key exclusion criteria (5 listed)
- Adult under guardianship
- Subject without national insurance cover
- Pregnant or breast-feeding women
- Patients with hip desarticulation
- Subjects presenting severe associated diseases affecting gait
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 |
|---|---|---|
| Locomotor evaluationcollection of parameters associated with walking and balance in patients with their usual prosthesis and then equipped with the new prosthesis | Other | – |
| QuestionnairesHoughton's scale, PPA-LCI, ABC, QEP, SF-12, SAT-PRO, ESAT | Other | – |
Primary outcome
Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis
Time frame: 12 months
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 18 Jun 2024.
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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 Lower Limb Amputation, run by Centre Hospitalier Universitaire Dijon 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 3 inclusion and 5 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 18 Jun 2024. 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?
Evolution of self-selected gait speed test, before and after the change or modification of the prosthesis (time frame: 12 months). 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 18 Jun 2024.