AmputeeNCT04330274
Comparison of Different Amputation Levels
An observational study of Amputee and Plantar Pressure Distrubution, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Amputee, Plantar Pressure Distrubution, Balance
- What is being tested?
- Bipedal with open eyes, Bipedal with closed eyes and Bipedal with open eyes and with platform
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Unilateral transtibial and transfemoral amputees
Who may be able to join
- Being unilateral transfemoral or transtibial amputee
- Have the level of perception to understand and apply the commands given
- Having sedantary life styles
Who cannot join
- Having a neurological or orthopedic disorder that may affect standing posture and balance
- The presence of pain that can affect standing posture and balance
- Visual impairment that impairs the gait pattern and balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Amputation Levels in Terms of Balance Parameters and Plantar Pressure Distribution; Lower Extremity
Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. The aim of this study is to reveal the relationship between amputation level-postural balance and amputation level-plantar pressure distribution.
- Conditions
- Amputee, Plantar Pressure Distrubution, Balance
- Being tested
- Bipedal with open eyes, Bipedal with closed eyes, Bipedal with open eyes and with platform, Bipedal with closed eyes and with platform
- Keywords
- amputee,plantar pressure, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipedal with open eyesOther
Standing bipedal with open eyes on force platform
Bipedal with closed eyesOther
Standing bipedal with closed eyes on force platform
Bipedal with open eyes and with platformOther
Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform
Bipedal with closed eyes and with platformOther
Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Unilateral transtibial amputee Receives: Other: Bipedal with open eyes; Other: Bipedal with closed eyes; Other: Bipedal with open eyes and with platform; Other: Bipedal with closed eyes and with platform | |
| Group 2 | Unilateral transfemoral amputee Receives: Other: Bipedal with open eyes; Other: Bipedal with closed eyes; Other: Bipedal with open eyes and with platform; Other: Bipedal with closed eyes and with platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of plantar pressure distrubution
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes
Measured: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Measurement of plantar pressure distrubution
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel
Measured: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Determination of center of pressure
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes
Measured: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel.
Measured: Change from baseline center of pressure at second 10, second 20 and second 30.
Measurement of plantar pressure distrubution
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes
Measured: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Measurement of plantar pressure distrubution
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel
Measured: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Determination of center of pressure
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes
Measured: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel.
Measured: Change from baseline center of pressure at second 10, second 20 and second 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Oct 2019
- Primary completion10 Feb 2020
- Study completion1 Jul 2020
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 AmputeeStudies 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
- 85 participants (actual)
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
- NCT04330274
- Sponsor's protocol ID
- 09.2019.357
- Status last verified
- Apr 2019
- First submitted
- 25 Mar 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jayakaran P, Johnson GM, Sullivan SJ. Postural control in response to altered sensory conditions in persons with dysvascular and traumatic transtibial amputation. Arch Phys Med Rehabil. 2015 Feb;96(2):331-9. doi: 10.1016/j.apmr.2014.09.037. Epub 2014 Oct 22.
PubMed 25450125Castro MP, Soares D, Mendes E, Machado L. Plantar pressures and ground reaction forces during walking of individuals with unilateral transfemoral amputation. PM R. 2014 Aug;6(8):698-707.e1. doi: 10.1016/j.pmrj.2014.01.019. Epub 2014 Jan 29.
PubMed 24487128Marks RM, Long JT, Exten EL. Gait abnormality following amputation in diabetic patients. Foot Ankle Clin. 2010 Sep;15(3):501-7. doi: 10.1016/j.fcl.2010.05.001.
PubMed 20682420Nolan L, Wit A, Dudzinski K, Lees A, Lake M, Wychowanski M. Adjustments in gait symmetry with walking speed in trans-femoral and trans-tibial amputees. Gait Posture. 2003 Apr;17(2):142-51. doi: 10.1016/s0966-6362(02)00066-8.
PubMed 12633775
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Amputation Levels in Terms of Balance Parameters and Plantar Pressure Distribution; Lower Extremity
- ClinicalTrials.gov ID
- NCT04330274
- Acronym / sponsor ID
- 09.2019.357
- Conditions
- Amputee, Plantar Pressure Distrubution, Balance
- Keywords
- amputee,plantar pressure, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 1 Apr 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.
Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. The aim of this study is to reveal the relationship between amputation level-postural balance and amputation level-plantar pressure distribution.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Bipedal with open eyes, Other: Bipedal with closed eyes, Other: Bipedal with open eyes and with platform, Other: Bipedal with closed eyes and with platformUnilateral transtibial amputee |
| Group 2 | – | Other: Bipedal with open eyes, Other: Bipedal with closed eyes, Other: Bipedal with open eyes and with platform, Other: Bipedal with closed eyes and with platformUnilateral transfemoral amputee |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unilateral transtibial and transfemoral amputees
Key inclusion criteria (3 listed)
- Being unilateral transfemoral or transtibial amputee
- Have the level of perception to understand and apply the commands given
- Having sedantary life styles
Key exclusion criteria (3 listed)
- Having a neurological or orthopedic disorder that may affect standing posture and balance
- The presence of pain that can affect standing posture and balance
- Visual impairment that impairs the gait pattern and balance
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 |
|---|---|---|
| Bipedal with open eyesStanding bipedal with open eyes on force platform | Other | Group 1, Group 2 |
| Bipedal with closed eyesStanding bipedal with closed eyes on force platform | Other | Group 1, Group 2 |
| Bipedal with open eyes and with platformStanding bipedal with open eyes and with platform under heel of prosthetic foot on force platform | Other | Group 1, Group 2 |
| Bipedal with closed eyes and with platformStanding bipedal with closed eyes and with platform under heel of prosthetic foot on force platform | Other | Group 1, Group 2 |
Primary outcome
Measurement of plantar pressure distrubution
Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes
Measurement of plantar pressure distrubution
Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel
Determination of center of pressure
Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes
Determination of center of pressure
Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel.
Measurement of plantar pressure distrubution
Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes
Measurement of plantar pressure distrubution
Time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel
Determination of center of pressure
Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes
Determination of center of pressure
Time frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel.
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 25 Jan 2022.
- Background: PubMed 25450125Jayakaran P, Johnson GM, Sullivan SJ. Postural control in response to altered sensory conditions in persons with dysvascular and traumatic transtibial amputation. Arch Phys Med Rehabil. 2015 Feb;96(2):331-9. doi: 10.1016/j.apmr.2014.09.037. Epub 2014 Oct 22.
- Background: PubMed 24487128Castro MP, Soares D, Mendes E, Machado L. Plantar pressures and ground reaction forces during walking of individuals with unilateral transfemoral amputation. PM R. 2014 Aug;6(8):698-707.e1. doi: 10.1016/j.pmrj.2014.01.019. Epub 2014 Jan 29.
- Background: PubMed 20682420Marks RM, Long JT, Exten EL. Gait abnormality following amputation in diabetic patients. Foot Ankle Clin. 2010 Sep;15(3):501-7. doi: 10.1016/j.fcl.2010.05.001.
- Background: PubMed 12633775Nolan L, Wit A, Dudzinski K, Lees A, Lake M, Wychowanski M. Adjustments in gait symmetry with walking speed in trans-femoral and trans-tibial amputees. Gait Posture. 2003 Apr;17(2):142-51. doi: 10.1016/s0966-6362(02)00066-8.
- Individual participant dataSharing planned: Undecided
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Amputation
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 Amputee and Plantar Pressure Distrubution, 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 3 inclusion and 3 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 25 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?
Measurement of plantar pressure distrubution (time frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.). 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 NCT04330274, 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 25 Jan 2022.