Transtibial AmputeeNCT04326712
The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
An observational study of Transtibial Amputee and Loading, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy. Recently, studies have been carried out to use 3D printers in socket production. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transtibial Amputee, Loading, Conventional
- What is being tested?
- conventional manufactured socket and 3D manufactured socket
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2019to 30 Jun 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unilateral transtibial amputees
Who may be able to join
- Being unilateral transtibial amputation
- To have enough perception level to understand and apply commands
Who cannot join
- To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait
- The presence of pain that will affect the posture or walking pattern
- Wound / tenderness on the stump
- Visual impairment that will affect the posture or gait pattern
- Use of any assistive device (walking stick, canary, etc.) during walking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses
Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy. Recently, studies have been carried out to use 3D printers in socket production. 3D method is accepted as an effective and reliable method in prosthetic socket production. The purpose of this study is to compare the pressures distrubution in the sockets produced by conventional and 3D scanners and printers in the transtibial amputee.
- Conditions
- Transtibial Amputee, Loading, Conventional, 3D
- Being tested
- conventional manufactured socket, 3D manufactured socket
- Keywords
- amputee, loading, 3D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional manufactured socketOther
Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
3D manufactured socketOther
Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Unilateral transtibial amputees using conventinional manufactured socket Receives: Other: conventional manufactured socket | |
| Group 2 | Unilateral transtibial amputees using 3D manufactured socket Receives: Other: 3D manufactured socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of load distrubution on stump in conventional manufactured socket
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.
Measured: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
Measurement of load distrubution on stump in 3D manufactured socket
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.
Measured: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
Measurement of load distrubution on stump in conventional manufactured socket
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
Measured: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
Measurement of load distrubution on stump in 3D-manufactured socket
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
Measured: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
Measured: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
Measured: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
Measured: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
Measured: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start6 Sep 2019
- Primary completion10 Apr 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transtibial AmputeeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yasar tatar, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326712
- Sponsor's protocol ID
- 09.2019.359
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. Clin Biomech (Bristol). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.
PubMed 16919376Jia X, Suo S, Meng F, Wang R. Effects of alignment on interface pressure for transtibial amputee during walking. Disabil Rehabil Assist Technol. 2008 Nov;3(6):339-43. doi: 10.1080/17483100802044634.
PubMed 19127605Xiaohong J, Xiaobing L, Peng D, Ming Z. The Influence of Dynamic Trans-tibial Prosthetic Alignment on Standing Plantar Foot Pressure. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6916-8. doi: 10.1109/IEMBS.2005.1616096.
PubMed 17281865Lee VS, Solomonidis SE, Spence WD. Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees--a preliminary study. Proc Inst Mech Eng H. 1997;211(2):167-80. doi: 10.1243/0954411971534287.
PubMed 9184457
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses
- ClinicalTrials.gov ID
- NCT04326712
- Acronym / sponsor ID
- 09.2019.359
- Conditions
- Transtibial Amputee, Loading, Conventional, 3D
- Keywords
- amputee, loading, 3D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 10 Apr 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 30 Mar 2020 (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.
Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy. Recently, studies have been carried out to use 3D printers in socket production. 3D method is accepted as an effective and reliable method in prosthetic socket production. The purpose of this study is to compare the pressures distrubution in the sockets produced by conventional and 3D scanners and printers in the transtibial amputee.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: conventional manufactured socketUnilateral transtibial amputees using conventinional manufactured socket |
| Group 2 | – | Other: 3D manufactured socketUnilateral transtibial amputees using 3D manufactured socket |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unilateral transtibial amputees
Key inclusion criteria (2 listed)
- Being unilateral transtibial amputation
- To have enough perception level to understand and apply commands
Key exclusion criteria (5 listed)
- To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait
- The presence of pain that will affect the posture or walking pattern
- Wound / tenderness on the stump
- Visual impairment that will affect the posture or gait pattern
- Use of any assistive device (walking stick, canary, etc.) during walking
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 |
|---|---|---|
| conventional manufactured socketPresssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees | Other | Group 1 |
| 3D manufactured socketPresssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees | Other | Group 2 |
Primary outcome
Measurement of load distrubution on stump in conventional manufactured socket
Time frame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.
Measurement of load distrubution on stump in 3D manufactured socket
Time frame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.
Measurement of load distrubution on stump in conventional manufactured socket
Time frame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
Measurement of load distrubution on stump in 3D-manufactured socket
Time frame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
Time frame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
Time frame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
Time frame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
Time frame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 16919376Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. Clin Biomech (Bristol). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.
- Background: PubMed 19127605Jia X, Suo S, Meng F, Wang R. Effects of alignment on interface pressure for transtibial amputee during walking. Disabil Rehabil Assist Technol. 2008 Nov;3(6):339-43. doi: 10.1080/17483100802044634.
- Background: PubMed 17281865Xiaohong J, Xiaobing L, Peng D, Ming Z. The Influence of Dynamic Trans-tibial Prosthetic Alignment on Standing Plantar Foot Pressure. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6916-8. doi: 10.1109/IEMBS.2005.1616096.
- Background: PubMed 9184457Lee VS, Solomonidis SE, Spence WD. Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees--a preliminary study. Proc Inst Mech Eng H. 1997;211(2):167-80. doi: 10.1243/0954411971534287.
- 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.
yasar tatar study director
Marmara University
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 Transtibial Amputee and Loading, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 30 Mar 2020. 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 Turkey (Türkiye). 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?
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?
Measurement of load distrubution on stump in conventional manufactured socket (time frame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking). The study lists 8 primary outcomes in all. 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 NCT04326712, which also lists 4 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 30 Mar 2020.