Analyzing Stump-socket Interface Pressure to Improve Gait in Above-knee Amputee
NCT ID: NCT01848964
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2013-04-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis is that an adapted prosthesis allowing an efficient gait in above-knee amputees corresponds to an homogeneous pressure distribution pattern onto the stump.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Pressure at the stump-socket interface will be recorded using a set of 14 single cells sensors placed in predefined positions onto the stump. Pattern of pressure will be measured in four tasks: sitting posture, standing posture, gait initiation, and gait at preferred velocity.
Reproducibility of the pressure repartition pattern will be analyzed by repeating gait and standing posture task in the first 15 patients included.
In patients whom prosthesis has been modified on the basis on the first pressure measurement (pressure peak and bad functional capacities), a new pressure measurement will be repeated 2-8 weeks apart.
Postural and gait abilities will be also assessed in 40 age/gender matched non-amputated subjects to serve as control data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Evaluation
First, the assessment will be performed to evaluate the relationship between pressure repartition pattern, clinical evaluation and motor capabilities. All the patients and volunteers will be concerned by this first part.
A second part will be conducted in 15 amputees within the 40 patients. Assessments of pressure pattern during gait and standing will be repeated two times: by the same investigator and by a different investigator, in order to test intra- and inter-evaluator reproducibility.
After the first assessment, the prosthesis may be modified in order to solve clinical problems. In that case, a new assessment will be proposed 2 to 8 weeks after in order to test the effect of the prosthesis modification on pressure pattern, gait, posture and clinical parameters.
Clinical and instrumented measurements
Clinical examination will include stump pain, wound, scar and unusual shape.
Questionnaire will include satisfaction scale (SatPro), comfort scale (SCE), and functional scale (PPA-LCI)
After installing the sensors on the stump, the patient will put his prosthesis on and will perform the following tasks: gait, sitting and standing posture and gait initiation.
Pressure repartition at the stump-socket interface will be assessed with the 14 flat sensors.
Gait parameters will be assessed with the OptoGait device. Standing posture and gait initiation parameters will be assessed with a force-plate.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical and instrumented measurements
Clinical examination will include stump pain, wound, scar and unusual shape.
Questionnaire will include satisfaction scale (SatPro), comfort scale (SCE), and functional scale (PPA-LCI)
After installing the sensors on the stump, the patient will put his prosthesis on and will perform the following tasks: gait, sitting and standing posture and gait initiation.
Pressure repartition at the stump-socket interface will be assessed with the 14 flat sensors.
Gait parameters will be assessed with the OptoGait device. Standing posture and gait initiation parameters will be assessed with a force-plate.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* use of a prosthesis with a "contact" socket
Exclusion Criteria
* Mini Mental State Examination below 24/30
2. Healthy subjects :
* neurological or muscular disorder likely to impair walking capabilities
* Mini Mental State Examination below 24/30
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TIMC-IMAG
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dominic Pérennou, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-A00219-36
Identifier Type: -
Identifier Source: org_study_id