AmputationSIGAMNCT02859740
Validation of the SIGAM/VF Mobility Grade
An observational study of Amputation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amputation
- What is being tested?
- SIGAM Questionnaire
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Mar 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with temporary or permanent prosthesis
Who may be able to join
- Aged 18 to 80 years
- Patients who have been informed about the research
- Patients with national health insurance cover
- Patients who accepted to take part in the study
- Able to understand simple instructions
- With transtibial, femoral, or bilateral amputation of the lower limb
Show all 12Show fewer
- Whatever the etiology
- Patients able to do the 2-minute walk test
- Group 1:
- Patients in the stabilized phase of the definitive prosthesis, with no modification of the prosthesis in the previous 3 months and at more than 6 months after the amputation.
- Group 2:
- Patients in the initial phase of management (temporary prosthesis, rehabilitation) post trans-tibial unilateral amputation
Who cannot join
- Patient without national health insurance cover.
- Patients under guardianship.
- Pregnant or breast-feeding women.
- Alteration of executive functions making understanding of and compliance with the research protocol impossible (Mini Mental State Examination<20)
- Associated chronic motor deficiency, of neurological origin (examples: sequelae of stroke, balance and coordination disorders), or of osteo-articular origin (examples: knee or hip osteoarthritis), or due to secondary functional repercussions making it impossible to walk with a prosthesis.
- Severe medical disorder that significantly impairs functional capacities (severe heart failure, respiratory failure, non-stabilized metabolic disorders such as progressive kidney failure) that is life-threatening in the short or medium term (Progressive neoplastic disease, non-stabilized systemic disease).
- Complications at the stump other than microcirculation that could affect the application of a contact socket/sleeve: haematoma, Cysts, effusion, calcifications of soft tissues, bone spurs, infection (skin, abscess), neuroma, deterioration of the knee of the amputated limb, specifically painful Farabeuf angle (compression between bone and skin), venous thrombosis, abnormal stump shape making it impossible to use a socket (flexion of the knee, "pear-shaped", "deep-scar" stump…)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.
- Conditions
- Amputation
- Being tested
- SIGAM Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIGAM QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| permanent prosthesis | Not described Receives: Other: SIGAM Questionnaire | |
| Temporary prosthesis | Not described Receives: Other: SIGAM Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Answers to the SIGAM mobility scale questionnaire
Measured: Change from baseline at Week 2 and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2013
- Primary completionMar 2014
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.
- 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
- 70 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
- NCT02859740
- Sponsor's protocol ID
- GREMEAUX JOUSSAIN 2013-3
- Acronym
- SIGAM
- Status last verified
- Jul 2016
- First submitted
- 2 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the SIGAM/VF Mobility Grade
- ClinicalTrials.gov ID
- NCT02859740
- Acronym / sponsor ID
- SIGAM / GREMEAUX JOUSSAIN 2013-3
- Conditions
- Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- First posted
- 9 Aug 2016 (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.
The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| permanent prosthesis | – | Other: SIGAM Questionnaire |
| Temporary prosthesis | – | Other: SIGAM Questionnaire |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with temporary or permanent prosthesis
Key inclusion criteria (12 listed)
- Aged 18 to 80 years
- Patients who have been informed about the research
- Patients with national health insurance cover
- Patients who accepted to take part in the study
- Able to understand simple instructions
Key exclusion criteria (7 listed)
- Patient without national health insurance cover.
- Patients under guardianship.
- Pregnant or breast-feeding women.
- Alteration of executive functions making understanding of and compliance with the research protocol impossible (Mini Mental State Examination<20)
- Associated chronic motor deficiency, of neurological origin (examples: sequelae of stroke, balance and coordination disorders), or of osteo-articular origin (examples: knee or hip osteoarthritis), or due to secondary functional repercussions making it impossible to walk with a prosthesis.
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 |
|---|---|---|
| SIGAM Questionnaire | Other | Temporary prosthesis, permanent prosthesis |
Primary outcome
Answers to the SIGAM mobility scale questionnaire
Time frame: Change from baseline at Week 2 and Week 3
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 9 Aug 2016.
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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, 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 12 inclusion and 7 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 9 Aug 2016. 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?
Answers to the SIGAM mobility scale questionnaire (time frame: Change from baseline at Week 2 and Week 3). 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 9 Aug 2016.