AmputationNCT02766387
Evaluation of Correlations Between Different Walk Tests in Patients With Transfemoral Amputees
A study testing Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test. in people with Amputation and Lower Extremity, run by University Hospital, Angers.
Trial summary
Lower limb amputation (LLA) is a major public health problem, with significant human and financial impact. Epidemiological data remain scarce in the literature. The primary objective of the equipment of lower limb amputees is to give a walking ability and autonomy that are closest to the previous state before the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Extremity
- What is being tested?
- Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2016to Oct 2016
- 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
- >18 years
- to be major, with a proximal lower extremity amputation (from knee disarticulation included until hemipelvectomy)
- to have a microprocessor controlled prosthetic knee among the 3C100C-leg, the RHEO Knee or HYBRID 1P360 for over a month
Who cannot join
- unstable angina or myocardial infarction dated less than one month,
- pregnancy or breastfeeding
- acute event responsible for a restriction in walking
- refusal to participate in the study
About this study
Official title: Evaluation of Correlations Between the 2 Minutes, 6 Minutes and 2 Kilometers Walk Tests in Patients With Transfemoral Amputees With a Microprocessor-controlled Prosthetic Knees
Lower limb amputation (LLA) is a major public health problem, with significant human and financial impact. Epidemiological data remain scarce in the literature. The primary objective of the equipment of lower limb amputees is to give a walking ability and autonomy that are closest to the previous state before the amputation. About microprocessor-controlled prosthetic knees (MPKs), there are currently three in France who benefit from support by health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France). These prostheses have the common feature of being equipped with a single-axis prosthetic knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking speed changes. They are indicated in the proximal amputations of the lower limbs from knee disarticulation included. Their prescription can only be made by a doctor of Physical Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et Prestations Remboursables). This criteria are the ability to: have a walking speed greater than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk down the stairs step by step. These criteria must be validated after a minimum trial period of 15 days.
These attribution criteria raise the question today of how they are measured, no recommendation defining this procedure. While many standardized assessment tests of different gait parameters are available and used in clinical research, the attribution criteria are not being built in reference to these tests.
The overall objective of the study is to evaluate the diagnostic value of two simple clinical tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).
- Conditions
- Amputation, Lower Extremity
- Being tested
- Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.Other
| Study group | Role | What they receive |
|---|---|---|
| 2 minutes walk test | Experimental | fast walk test during 2 minutes in first and the 10 meters walk test, the 6 minutes walk test and the 2 kilometers walk test Receives: Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test. |
| 6 minutes walk test | Experimental | comfortable walk test during 6 minutes in first and the 10 meters walk test, the 2 minutes walk test and the 2 kilometers walk test Receives: Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
- The percentage of variance of the speed of the continuous 2km walk test and 10 meters walk test explained by the velocity estimated respectively by the 2MWT and the 6 MWT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
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 University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766387
- Sponsor's protocol ID
- 2016-A00054-47
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Correlations Between the 2 Minutes, 6 Minutes and 2 Kilometers Walk Tests in Patients With Transfemoral Amputees With a Microprocessor-controlled Prosthetic Knees
- ClinicalTrials.gov ID
- NCT02766387
- Acronym / sponsor ID
- 2016-A00054-47
- Conditions
- Amputation, Lower Extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 May 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.
Lower limb amputation (LLA) is a major public health problem, with significant human and financial impact. Epidemiological data remain scarce in the literature. The primary objective of the equipment of lower limb amputees is to give a walking ability and autonomy that are closest to the previous state before the amputation. About microprocessor-controlled prosthetic knees (MPKs), there are currently three in France who benefit from support by health insurance : 3C100 knee C-leg (Otto Bock HealthCare, Duderstadt, Germany), the Rheo Knee (Ossur, Reykjavik, Iceland) and knee HYBRID 1P360 (Proteor, Saint Apollinaire, France). These prostheses have the common feature of being equipped with a single-axis prosthetic knee, controlled by a microprocessor, wich allows to adapt instantly to the user's walking speed changes. They are indicated in the proximal amputations of the lower limbs from knee disarticulation included. Their prescription can only be made by a doctor of Physical Medicine and Rehabilitation. These prostheses are subject to four criteria attribution and reimbursement by the List of Products and Services Refundable (LPPR = Liste des Produits et Prestations Remboursables). This criteria are the ability to: have a walking speed greater than or equal to 4 km/h, walk 2km continuous, descend an inclined slop of 15% and to walk down the stairs step by step. These criteria must be validated after a minimum trial period of 15 days.
These attribution criteria raise the question today of how they are measured, no recommendation defining this procedure. While many standardized assessment tests of different gait parameters are available and used in clinical research, the attribution criteria are not being built in reference to these tests.
The overall objective of the study is to evaluate the diagnostic value of two simple clinical tests, the 2 and 6 minutes walk tests, to assess functional performance in patients with transfemoral amputees with a microprocessor-controlled Prosthetic Knees (MPKs).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 minutes walk test | Experimental | Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.fast walk test during 2 minutes in first and the 10 meters walk test, the 6 minutes walk test and the 2 kilometers walk test |
| 6 minutes walk test | Experimental | Other: Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.comfortable walk test during 6 minutes in first and the 10 meters walk test, the 2 minutes walk test and the 2 kilometers walk test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years
- to be major, with a proximal lower extremity amputation (from knee disarticulation included until hemipelvectomy)
- to have a microprocessor controlled prosthetic knee among the 3C100C-leg, the RHEO Knee or HYBRID 1P360 for over a month
Key exclusion criteria (4 listed)
- unstable angina or myocardial infarction dated less than one month,
- pregnancy or breastfeeding
- acute event responsible for a restriction in walking
- refusal to participate in the study
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 |
|---|---|---|
| Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test. | Other | 2 minutes walk test, 6 minutes walk test |
Primary outcome
- The percentage of variance of the speed of the continuous 2km walk test and 10 meters walk test explained by the velocity estimated respectively by the 2MWT and the 6 MWT
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test. in people with Amputation and Lower Extremity, run by University Hospital, Angers.
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 4 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 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
- The percentage of variance of the speed of the continuous 2km walk test and 10 meters walk test explained by the velocity estimated respectively by the 2MWT and the 6 MWT (time frame: 3 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 9 May 2016.