Amputation StumpNCT04709367
Characterization of Residual Limb Volume Changes in Transfemoral Amputees
An observational study of Amputation Stump, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
Trial summary
This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation Stump
- What is being tested?
- 3D optical scan
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2018to 30 Sep 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: transfemoral amputees
Who may be able to join
- Stabilized (i.e., time since amputation > 18 months) transfemoral amputees
- Age between 18 and 65 years old
- Subjects able to safely perform the physical tasks required in the experimental protocol
- Subjects provided with prostheses
Who cannot join
- Denial of informed consent to participate in the study
- Inability to maintain the required position during the 3D scanning for at least 5 minutes
- Concomitant general or localized comorbidities / disabilities, which may interfere with the study
- Pathological conditions affecting the residual limb
- Allergy / sensitivity with polydimethylsiloxane (PDMS)
- Pathological cardiopulmonary / cardiovascular conditions
Show all 12Show fewer
- Pregnancy or breastfeeding
- Presence of psychiatric co-morbidities
- Presence of cognitive deficits which may compromise the understanding of the required tasks
- Difficulty in understanding the Italian language
- Insufficient degree of collaboration
- Consumption of alcohol or diuretics before tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.
This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.
Read the detailed description
The first test session aims at measuring residual limb volume at 7 time-points, with 10 minute intervals, after prosthesis doffing. This allows for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee are captured to evaluate volume changes due to prosthesis removal and physical activity, in two times per day (one in the morning, one in the afternoon). These measurements are repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee.
- Conditions
- Amputation Stump
- Being tested
- 3D optical scan
- Keywords
- Amputee, Prosthetic socket, Transfemoral residual limb, Volume change, 3D scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D optical scanOther
The clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon.
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual limb volume changes
Residual limb volume changes due to prosthesis doffing, physical activity, and testing time are measured by a proper experimental set-up, including a 3D metrology-grade optical scanner.
Measured: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Secondary outcomes (1)
Pressure distribution at the prosthetic socket - residual limb interface
Pressure distributions at the residual limb/ socket interface are measured by the F-Socket Pressure Measurement System, during:
- Walking (five gait cycles, three times);
- Walking up and down slope (five gait cycles, three times);
- Walking upstairs and downstairs (six stairs cycles, three times);
- Sitting down and up (three times).
Measured: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start11 May 2018
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amputation StumpStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor
- Investigators
- Emanuele Gruppioni, Principal investigator, INAIL Prosthesis Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709367
- Sponsor's protocol ID
- P-PPRAI1/2-01
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paterno L, Truppa L, Ibrahimi M, Rosini E, Gruppioni E, Ricotti L, Menciassi A. Quantitative analysis of interface pressures in transfemoral prosthetic sockets. Prosthet Orthot Int. 2024 Apr 1;48(2):176-183. doi: 10.1097/PXR.0000000000000251. Epub 2023 Jun 28.
PubMed 37379468Paterno L, Ibrahimi M, Rosini E, Menfi G, Monaco V, Gruppioni E, Ricotti L, Menciassi A. Residual limb volume fluctuations in transfemoral amputees. Sci Rep. 2021 Jun 10;11(1):12273. doi: 10.1038/s41598-021-91647-9.
PubMed 34112873
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Residual Limb Volume Changes in Transfemoral Amputees: Descriptive Prospective Longitudinal Observational Study.
- ClinicalTrials.gov ID
- NCT04709367
- Acronym / sponsor ID
- P-PPRAI1/2-01
- Conditions
- Amputation Stump
- Keywords
- Amputee, Prosthetic socket, Transfemoral residual limb, Volume change, 3D scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 11 May 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 14 Jan 2021 (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.
This study quantifies residual limb volume fluctuations affecting transfemoral amputees due to the prosthesis doffing, physical activity, and testing time.
Detailed description
The first test session aims at measuring residual limb volume at 7 time-points, with 10 minute intervals, after prosthesis doffing. This allows for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee are captured to evaluate volume changes due to prosthesis removal and physical activity, in two times per day (one in the morning, one in the afternoon). These measurements are repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- transfemoral amputees
Key inclusion criteria (4 listed)
- Stabilized (i.e., time since amputation > 18 months) transfemoral amputees
- Age between 18 and 65 years old
- Subjects able to safely perform the physical tasks required in the experimental protocol
- Subjects provided with prostheses
Key exclusion criteria (12 listed)
- Denial of informed consent to participate in the study
- Inability to maintain the required position during the 3D scanning for at least 5 minutes
- Concomitant general or localized comorbidities / disabilities, which may interfere with the study
- Pathological conditions affecting the residual limb
- Allergy / sensitivity with polydimethylsiloxane (PDMS)
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 |
|---|---|---|
| 3D optical scanThe clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon. | Other | – |
Primary outcome
Residual limb volume changes
Time frame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
Residual limb volume changes due to prosthesis doffing, physical activity, and testing time are measured by a proper experimental set-up, including a 3D metrology-grade optical scanner.
1 secondary outcome
Pressure distribution at the prosthetic socket - residual limb interface
Time frame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks
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 14 Jan 2021.
- Derived from this study: PubMed 37379468Paterno L, Truppa L, Ibrahimi M, Rosini E, Gruppioni E, Ricotti L, Menciassi A. Quantitative analysis of interface pressures in transfemoral prosthetic sockets. Prosthet Orthot Int. 2024 Apr 1;48(2):176-183. doi: 10.1097/PXR.0000000000000251. Epub 2023 Jun 28.
- Derived from this study: PubMed 34112873Paterno L, Ibrahimi M, Rosini E, Menfi G, Monaco V, Gruppioni E, Ricotti L, Menciassi A. Residual limb volume fluctuations in transfemoral amputees. Sci Rep. 2021 Jun 10;11(1):12273. doi: 10.1038/s41598-021-91647-9.
- 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.
Emanuele Gruppioni principal investigator
INAIL Prosthesis Centre
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 Stump, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
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 4 inclusion and 12 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 14 Jan 2021. 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 Italy. 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?
Residual limb volume changes (time frame: The protocol consisted of four test sessions in four different days for an overall duration of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709367, which also lists 2 linked publications.
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 14 Jan 2021.