Amputation; Traumatic, LimbNCT04456244
Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
An observational study of Amputation; Traumatic, Limb and Postural; Defect, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Amputation; Traumatic, Limb, Postural; Defect
- What is being tested?
- Evaluation of the static posture
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2021to 30 Jan 2021
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: With Unilateral Transfemoral and Transtibial Amputation Patients
Who may be able to join
- Being between the ages of 18-65
- Having had an amputation at least 6 months ago
- Have had transfemoral amputation or transtibial amputation
- To be able to perform ambulation independently
Who cannot join
- mental inability to understand commands
- have a neurological, orthopedic and systemic problem that will negatively affect posture or gait.
Trial locations and contacts
1 site in 1 country.
About this study
With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. The aim of this study is to determine the static postural adaptations that appear at different amputation levels.
- Conditions
- Amputation; Traumatic, Limb, Postural; Defect
- Being tested
- Evaluation of the static posture
- Keywords
- amputation, postural adaptations, transtibial, transfemoral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the static postureOther
Photographing from the back, front and side with ADIBAS posturography in standing position
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Transtibial Amputation | Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis. Receives: Other: Evaluation of the static posture | |
| Group 2:Transfemoral Amputation | Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis. Receives: Other: Evaluation of the static posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the static posture-1
Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in free standing position
Measured: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Evaluation of the static posture-2
Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in equal weighting on platform (3D L.A.S.A.R. Posture, 743L500, Ottobock)
Measured: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Evaluation of the back pain
Pain will be evaluated by using Visual Analog Scale ranging 0(no pain)-10(worst pain)
Measured: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start3 Jan 2021
- Primary completion23 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Amputation; Traumatic, LimbStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Responsible party
- Sponsor
- Investigators
- Nilüfer Kablan, PhD, Principal investigator, Istanbul Sağlık Bilimleri Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456244
- Sponsor's protocol ID
- 19/164
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Silverman AK, Fey NP, Portillo A, Walden JG, Bosker G, Neptune RR. Compensatory mechanisms in below-knee amputee gait in response to increasing steady-state walking speeds. Gait Posture. 2008 Nov;28(4):602-9. doi: 10.1016/j.gaitpost.2008.04.005. Epub 2008 Jun 2.
PubMed 18514526Hendershot BD, Nussbaum MA. Persons with lower-limb amputation have impaired trunk postural control while maintaining seated balance. Gait Posture. 2013 Jul;38(3):438-42. doi: 10.1016/j.gaitpost.2013.01.008. Epub 2013 Feb 4.
PubMed 23391751Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
PubMed 18566923Molina-Rueda F, Alguacil-Diego IM, Cuesta-Gomez A, Iglesias-Gimenez J, Martin-Vivaldi A, Miangolarra-Page JC. Thorax, pelvis and hip pattern in the frontal plane during walking in unilateral transtibial amputees: biomechanical analysis. Braz J Phys Ther. 2014 May-Jun;18(3):252-8. doi: 10.1590/bjpt-rbf.2014.0032.
PubMed 25003278Kulkarni J, Gaine WJ, Buckley JG, Rankine JJ, Adams J. Chronic low back pain in traumatic lower limb amputees. Clin Rehabil. 2005 Jan;19(1):81-6. doi: 10.1191/0269215505cr819oa.
PubMed 15704512Soares AS, Yamaguti EY, Mochizuki L, Amadio AC, Serrao JC. Biomechanical parameters of gait among transtibial amputees: a review. Sao Paulo Med J. 2009 Sep;127(5):302-9. doi: 10.1590/s1516-31802009000500010.
PubMed 20169280Lloyd CH, Stanhope SJ, Davis IS, Royer TD. Strength asymmetry and osteoarthritis risk factors in unilateral trans-tibial, amputee gait. Gait Posture. 2010 Jul;32(3):296-300. doi: 10.1016/j.gaitpost.2010.05.003. Epub 2010 Aug 1.
PubMed 20678938Khamis S, Carmeli E. The effect of simulated leg length discrepancy on lower limb biomechanics during gait. Gait Posture. 2018 Mar;61:73-80. doi: 10.1016/j.gaitpost.2017.12.024. Epub 2017 Dec 28.
PubMed 29306147Carmona GA, Hoffmeyer P, Herrmann FR, Vaucher J, Tschopp O, Lacraz A, Vischer UM. Major lower limb amputations in the elderly observed over ten years: the role of diabetes and peripheral arterial disease. Diabetes Metab. 2005 Nov;31(5):449-54. doi: 10.1016/s1262-3636(07)70215-x.
PubMed 16357788Gaffney BM, Murray AM, Christiansen CL, Davidson BS. Identification of trunk and pelvis movement compensations in patients with transtibial amputation using angular momentum separation. Gait Posture. 2016 Mar;45:151-6. doi: 10.1016/j.gaitpost.2016.01.015. Epub 2016 Jan 25.
PubMed 26979898
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
- ClinicalTrials.gov ID
- NCT04456244
- Acronym / sponsor ID
- 19/164
- Conditions
- Amputation; Traumatic, Limb, Postural; Defect
- Keywords
- amputation, postural adaptations, transtibial, transfemoral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 2 Jul 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.
With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. The aim of this study is to determine the static postural adaptations that appear at different amputation levels.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Transtibial Amputation | – | Other: Evaluation of the static posturePhotographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis. |
| Group 2:Transfemoral Amputation | – | Other: Evaluation of the static posturePhotographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- With Unilateral Transfemoral and Transtibial Amputation Patients
Key inclusion criteria (4 listed)
- Being between the ages of 18-65
- Having had an amputation at least 6 months ago
- Have had transfemoral amputation or transtibial amputation
- To be able to perform ambulation independently
Key exclusion criteria (2 listed)
- mental inability to understand commands
- have a neurological, orthopedic and systemic problem that will negatively affect posture or gait.
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 static posturePhotographing from the back, front and side with ADIBAS posturography in standing position | Other | Group 1:Transtibial Amputation, Group 2:Transfemoral Amputation |
Primary outcome
Evaluation of the static posture-1
Time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in free standing position
Evaluation of the static posture-2
Time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in equal weighting on platform (3D L.A.S.A.R. Posture, 743L500, Ottobock)
Evaluation of the back pain
Time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Pain will be evaluated by using Visual Analog Scale ranging 0(no pain)-10(worst pain)
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 20 Jan 2022.
- Results publication: PubMed 18514526Silverman AK, Fey NP, Portillo A, Walden JG, Bosker G, Neptune RR. Compensatory mechanisms in below-knee amputee gait in response to increasing steady-state walking speeds. Gait Posture. 2008 Nov;28(4):602-9. doi: 10.1016/j.gaitpost.2008.04.005. Epub 2008 Jun 2.
- Results publication: PubMed 23391751Hendershot BD, Nussbaum MA. Persons with lower-limb amputation have impaired trunk postural control while maintaining seated balance. Gait Posture. 2013 Jul;38(3):438-42. doi: 10.1016/j.gaitpost.2013.01.008. Epub 2013 Feb 4.
- Results publication: PubMed 18566923Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
- Results publication: PubMed 25003278Molina-Rueda F, Alguacil-Diego IM, Cuesta-Gomez A, Iglesias-Gimenez J, Martin-Vivaldi A, Miangolarra-Page JC. Thorax, pelvis and hip pattern in the frontal plane during walking in unilateral transtibial amputees: biomechanical analysis. Braz J Phys Ther. 2014 May-Jun;18(3):252-8. doi: 10.1590/bjpt-rbf.2014.0032.
- Results publication: PubMed 15704512Kulkarni J, Gaine WJ, Buckley JG, Rankine JJ, Adams J. Chronic low back pain in traumatic lower limb amputees. Clin Rehabil. 2005 Jan;19(1):81-6. doi: 10.1191/0269215505cr819oa.
- Results publication: PubMed 20169280Soares AS, Yamaguti EY, Mochizuki L, Amadio AC, Serrao JC. Biomechanical parameters of gait among transtibial amputees: a review. Sao Paulo Med J. 2009 Sep;127(5):302-9. doi: 10.1590/s1516-31802009000500010.
- Results publication: PubMed 20678938Lloyd CH, Stanhope SJ, Davis IS, Royer TD. Strength asymmetry and osteoarthritis risk factors in unilateral trans-tibial, amputee gait. Gait Posture. 2010 Jul;32(3):296-300. doi: 10.1016/j.gaitpost.2010.05.003. Epub 2010 Aug 1.
- Results publication: PubMed 29306147Khamis S, Carmeli E. The effect of simulated leg length discrepancy on lower limb biomechanics during gait. Gait Posture. 2018 Mar;61:73-80. doi: 10.1016/j.gaitpost.2017.12.024. Epub 2017 Dec 28.
- Results publication: PubMed 16357788Carmona GA, Hoffmeyer P, Herrmann FR, Vaucher J, Tschopp O, Lacraz A, Vischer UM. Major lower limb amputations in the elderly observed over ten years: the role of diabetes and peripheral arterial disease. Diabetes Metab. 2005 Nov;31(5):449-54. doi: 10.1016/s1262-3636(07)70215-x.
- Results publication: PubMed 26979898Gaffney BM, Murray AM, Christiansen CL, Davidson BS. Identification of trunk and pelvis movement compensations in patients with transtibial amputation using angular momentum separation. Gait Posture. 2016 Mar;45:151-6. doi: 10.1016/j.gaitpost.2016.01.015. Epub 2016 Jan 25.
- 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.
Nilüfer Kablan, PhD principal investigator
Istanbul Sağlık Bilimleri Üniversitesi
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; Traumatic, Limb and Postural; Defect, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 4 inclusion and 2 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 20 Jan 2022. 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?
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?
Evaluation of the static posture-1 (time frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test). The study lists 3 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 NCT04456244, which also lists 10 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 20 Jan 2022.