Amputees / RehabilitationNCT06827119
Relationship Between Prosthesis Adaptation and Functional Mobility
An observational study of Amputees / Rehabilitation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the relationships between locomotor skills, timed performance, gait parameters, balance, fear of falling, and prosthesis satisfaction in individuals who underwent amputation due to an earthquake. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputees / Rehabilitation
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2023to 19 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People admitted to Ankara Bilkent City Hospital
Who may be able to join
- Being over 18 years old
- Having a lower extremity amputation
- Being in the prosthetic period
- Being at K1 functional level or above
- Agreeing to participate in the study voluntarily
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06690
About this study
Official title: Investigation of the Relationship Between Lower Limb Prosthesis Usage Skills and Adaptation Level with Functional Mobility and Activities of Daily Living
This study investigates the relationships between locomotor skills, timed performance, gait parameters, balance, fear of falling, and prosthesis satisfaction in individuals who underwent amputation due to an earthquake. Conducted at Ankara Bilkent City Hospital, it included participants aged 18 years and older who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level.
Read the detailed description
Lower limb amputation significantly affects an individual's mobility, balance, and overall quality of life. The impact is even more pronounced in individuals who have undergone amputation due to traumatic events such as earthquakes. Understanding the factors influencing locomotor performance, balance, and prosthesis satisfaction in this specific population is crucial for optimizing rehabilitation strategies and improving functional outcomes.
This study was conducted at Ankara Bilkent City Hospital and included participants aged 18 years and older, who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level. Participants underwent a series of assessments related to gait, balance, locomotor skills, timed performance, and prosthesis satisfaction. Data were analyzed using correlation analyses, taking into account normality distribution.
The study contributes to the existing literature by highlighting the importance of comprehensive rehabilitation programs that address both physical and psychological aspects of prosthesis adaptation. Future research should focus on larger sample sizes, longer follow-up periods, and the influence of psychosocial factors and rehabilitation approaches on prosthesis satisfaction and functional outcomes.
- Conditions
- Amputees / Rehabilitation
- Keywords
- Earthquake, Amputees, Gait Analysis, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Earthquake survivor amputees |
What is being measured
The primary outcome is the main question the study is designed to answer.
K level clasification
The K-level classification was developed by the Centers for Medicare and Medicaid Services (CMS) to determine the current and potential functional mobility levels of prosthetic users. This system rates individuals from K0 (no ability or potential for ambulation with a prosthesis) to K4 (able to use a prosthesis in high-level activities), and it is used as a standardized assessment tool in the prosthetic prescription and reimbursement processes.
Measured: Assessed at a single study visit during the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start19 Jul 2023
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Amputees / RehabilitationStudies 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
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827119
- Sponsor's protocol ID
- E2-23-4575
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Batten HR, McPhail SM, Mandrusiak AM, Varghese PN, Kuys SS. Gait speed as an indicator of prosthetic walking potential following lower limb amputation. Prosthet Orthot Int. 2019 Apr;43(2):196-203. doi: 10.1177/0309364618792723. Epub 2018 Aug 16.
PubMed 30112982Wong CK, Chen CC, Benoy SA, Rahal RT, Blackwell WM. Role of balance ability and confidence in prosthetic use for mobility of people with lower-limb loss. J Rehabil Res Dev. 2014;51(9):1353-64. doi: 10.1682/JRRD.2013.11.0235.
PubMed 25785790Zhang X, Liu Z, Qiu G. Measuring Balance Abilities of Transtibial Amputees Using Multiattribute Utility Theory. Biomed Res Int. 2021 Dec 21;2021:8340367. doi: 10.1155/2021/8340367. eCollection 2021.
PubMed 34970628Abou L, de Freitas GR, Palandi J, Ilha J. Clinical Instruments for Measuring Unsupported Sitting Balance in Subjects with Spinal Cord Injury: A Systematic Review. Top Spinal Cord Inj Rehabil. 2018 Spring;24(2):177-193. doi: 10.1310/sci17-00027. Epub 2018 Feb 12.
PubMed 29706762Quinzanos-Fresnedo J, Fratini-Escobar PC, Almaguer-Benavides KM, Aguirre-Guemez AV, Barrera-Ortiz A, Perez-Zavala R, Villa-Romero AR. Prognostic validity of a clinical trunk control test for independence and walking in individuals with spinal cord injury. J Spinal Cord Med. 2020 May;43(3):331-338. doi: 10.1080/10790268.2018.1518124. Epub 2018 Sep 12.
PubMed 30207875Arifin N, Abu Osman NA, Ali S, Gholizadeh H, Abas WA. Postural stability characteristics of transtibial amputees wearing different prosthetic foot types when standing on various support surfaces. ScientificWorldJournal. 2014;2014:856279. doi: 10.1155/2014/856279. Epub 2014 Jun 5.
PubMed 25003155Wirz M, Muller R, Bastiaenen C. Falls in persons with spinal cord injury: validity and reliability of the Berg Balance Scale. Neurorehabil Neural Repair. 2010 Jan;24(1):70-7. doi: 10.1177/1545968309341059. Epub 2009 Aug 12.
PubMed 19675123Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.
PubMed 18489806van Ooijen MW, Heeren A, Smulders K, Geurts AC, Janssen TW, Beek PJ, Weerdesteyn V, Roerdink M. Improved gait adjustments after gait adaptability training are associated with reduced attentional demands in persons with stroke. Exp Brain Res. 2015 Mar;233(3):1007-18. doi: 10.1007/s00221-014-4175-7. Epub 2014 Dec 24.
PubMed 25537466Deathe AB, Wolfe DL, Devlin M, Hebert JS, Miller WC, Pallaveshi L. Selection of outcome measures in lower extremity amputation rehabilitation: ICF activities. Disabil Rehabil. 2009;31(18):1455-73. doi: 10.1080/09638280802639491.
PubMed 19479574Jackson AB, Carnel CT, Ditunno JF, Read MS, Boninger ML, Schmeler MR, Williams SR, Donovan WH; Gait and Ambulation Subcommittee. Outcome measures for gait and ambulation in the spinal cord injury population. J Spinal Cord Med. 2008;31(5):487-99. doi: 10.1080/10790268.2008.11753644.
PubMed 19086706Bolliger M, Blight AR, Field-Fote EC, Musselman K, Rossignol S, Barthelemy D, Bouyer L, Popovic MR, Schwab JM, Boninger ML, Tansey KE, Scivoletto G, Kleitman N, Jones LAT, Gagnon DH, Nadeau S, Haupt D, Awai L, Easthope CS, Zorner B, Rupp R, Lammertse D, Curt A, Steeves J. Lower extremity outcome measures: considerations for clinical trials in spinal cord injury. Spinal Cord. 2018 Jul;56(7):628-642. doi: 10.1038/s41393-018-0097-8. Epub 2018 Apr 27.
PubMed 29700477Martinez-Martin E, Cazorla M. Rehabilitation Technology: Assistance from Hospital to Home. Comput Intell Neurosci. 2019 Jun 2;2019:1431509. doi: 10.1155/2019/1431509. eCollection 2019.
PubMed 31281333Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8. doi: 10.1016/j.apmr.2003.06.010.
PubMed 15129398Hordacre B, Birks V, Quinn S, Barr C, Patritti BL, Crotty M. Physiotherapy rehabilitation for individuals with lower limb amputation: a 15-year clinical series. Physiother Res Int. 2013 Jun;18(2):70-80. doi: 10.1002/pri.1529. Epub 2012 Jun 6.
PubMed 22674875
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Lower Limb Prosthesis Usage Skills and Adaptation Level with Functional Mobility and Activities of Daily Living
- ClinicalTrials.gov ID
- NCT06827119
- Acronym / sponsor ID
- E2-23-4575
- Conditions
- Amputees / Rehabilitation
- Keywords
- Earthquake, Amputees, Gait Analysis, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 14 Feb 2025 (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 investigates the relationships between locomotor skills, timed performance, gait parameters, balance, fear of falling, and prosthesis satisfaction in individuals who underwent amputation due to an earthquake. Conducted at Ankara Bilkent City Hospital, it included participants aged 18 years and older who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level.
Detailed description
Lower limb amputation significantly affects an individual's mobility, balance, and overall quality of life. The impact is even more pronounced in individuals who have undergone amputation due to traumatic events such as earthquakes. Understanding the factors influencing locomotor performance, balance, and prosthesis satisfaction in this specific population is crucial for optimizing rehabilitation strategies and improving functional outcomes.
This study was conducted at Ankara Bilkent City Hospital and included participants aged 18 years and older, who were in the prosthetic rehabilitation phase and classified at or above the K1 functional level. Participants underwent a series of assessments related to gait, balance, locomotor skills, timed performance, and prosthesis satisfaction. Data were analyzed using correlation analyses, taking into account normality distribution.
The study contributes to the existing literature by highlighting the importance of comprehensive rehabilitation programs that address both physical and psychological aspects of prosthesis adaptation. Future research should focus on larger sample sizes, longer follow-up periods, and the influence of psychosocial factors and rehabilitation approaches on prosthesis satisfaction and functional outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Earthquake survivor amputees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People admitted to Ankara Bilkent City Hospital
Key inclusion criteria (5 listed)
- Being over 18 years old
- Having a lower extremity amputation
- Being in the prosthetic period
- Being at K1 functional level or above
- Agreeing to participate in the study voluntarily
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
K level clasification
Time frame: Assessed at a single study visit during the 12-month study period.
The K-level classification was developed by the Centers for Medicare and Medicaid Services (CMS) to determine the current and potential functional mobility levels of prosthetic users. This system rates individuals from K0 (no ability or potential for ambulation with a prosthesis) to K4 (able to use a prosthesis in high-level activities), and it is used as a standardized assessment tool in the prosthetic prescription and reimbursement processes.
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 Feb 2025.
- Background: PubMed 30112982Batten HR, McPhail SM, Mandrusiak AM, Varghese PN, Kuys SS. Gait speed as an indicator of prosthetic walking potential following lower limb amputation. Prosthet Orthot Int. 2019 Apr;43(2):196-203. doi: 10.1177/0309364618792723. Epub 2018 Aug 16.
- Background: PubMed 25785790Wong CK, Chen CC, Benoy SA, Rahal RT, Blackwell WM. Role of balance ability and confidence in prosthetic use for mobility of people with lower-limb loss. J Rehabil Res Dev. 2014;51(9):1353-64. doi: 10.1682/JRRD.2013.11.0235.
- Background: PubMed 34970628Zhang X, Liu Z, Qiu G. Measuring Balance Abilities of Transtibial Amputees Using Multiattribute Utility Theory. Biomed Res Int. 2021 Dec 21;2021:8340367. doi: 10.1155/2021/8340367. eCollection 2021.
- Background: PubMed 29706762Abou L, de Freitas GR, Palandi J, Ilha J. Clinical Instruments for Measuring Unsupported Sitting Balance in Subjects with Spinal Cord Injury: A Systematic Review. Top Spinal Cord Inj Rehabil. 2018 Spring;24(2):177-193. doi: 10.1310/sci17-00027. Epub 2018 Feb 12.
- Background: PubMed 30207875Quinzanos-Fresnedo J, Fratini-Escobar PC, Almaguer-Benavides KM, Aguirre-Guemez AV, Barrera-Ortiz A, Perez-Zavala R, Villa-Romero AR. Prognostic validity of a clinical trunk control test for independence and walking in individuals with spinal cord injury. J Spinal Cord Med. 2020 May;43(3):331-338. doi: 10.1080/10790268.2018.1518124. Epub 2018 Sep 12.
- Background: PubMed 25003155Arifin N, Abu Osman NA, Ali S, Gholizadeh H, Abas WA. Postural stability characteristics of transtibial amputees wearing different prosthetic foot types when standing on various support surfaces. ScientificWorldJournal. 2014;2014:856279. doi: 10.1155/2014/856279. Epub 2014 Jun 5.
- Background: PubMed 19675123Wirz M, Muller R, Bastiaenen C. Falls in persons with spinal cord injury: validity and reliability of the Berg Balance Scale. Neurorehabil Neural Repair. 2010 Jan;24(1):70-7. doi: 10.1177/1545968309341059. Epub 2009 Aug 12.
- Background: PubMed 18489806Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.
- Background: PubMed 25537466van Ooijen MW, Heeren A, Smulders K, Geurts AC, Janssen TW, Beek PJ, Weerdesteyn V, Roerdink M. Improved gait adjustments after gait adaptability training are associated with reduced attentional demands in persons with stroke. Exp Brain Res. 2015 Mar;233(3):1007-18. doi: 10.1007/s00221-014-4175-7. Epub 2014 Dec 24.
- Background: PubMed 19479574Deathe AB, Wolfe DL, Devlin M, Hebert JS, Miller WC, Pallaveshi L. Selection of outcome measures in lower extremity amputation rehabilitation: ICF activities. Disabil Rehabil. 2009;31(18):1455-73. doi: 10.1080/09638280802639491.
- Background: PubMed 19086706Jackson AB, Carnel CT, Ditunno JF, Read MS, Boninger ML, Schmeler MR, Williams SR, Donovan WH; Gait and Ambulation Subcommittee. Outcome measures for gait and ambulation in the spinal cord injury population. J Spinal Cord Med. 2008;31(5):487-99. doi: 10.1080/10790268.2008.11753644.
- Background: PubMed 29700477Bolliger M, Blight AR, Field-Fote EC, Musselman K, Rossignol S, Barthelemy D, Bouyer L, Popovic MR, Schwab JM, Boninger ML, Tansey KE, Scivoletto G, Kleitman N, Jones LAT, Gagnon DH, Nadeau S, Haupt D, Awai L, Easthope CS, Zorner B, Rupp R, Lammertse D, Curt A, Steeves J. Lower extremity outcome measures: considerations for clinical trials in spinal cord injury. Spinal Cord. 2018 Jul;56(7):628-642. doi: 10.1038/s41393-018-0097-8. Epub 2018 Apr 27.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Amputees / Rehabilitation, run by Ankara City Hospital Bilkent 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 5 inclusion and 0 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 Feb 2025. 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?
K level clasification (time frame: Assessed at a single study visit during the 12-month study period.). 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 NCT06827119, which also lists 19 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 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.