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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06827119
Study groupRoleWhat they receive
CasesEarthquake survivor amputees

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted14 Feb 2025
  2. Study start19 Jul 2023
  3. Primary completion19 Jul 2024
  4. Study completion19 Jul 2024

Resources

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)
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 30112982

  • Wong 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 25785790

  • Zhang 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 34970628

  • Abou 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 29706762

  • Quinzanos-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 30207875

  • Arifin 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 25003155

  • Wirz 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 19675123

  • Sahin 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 18489806

  • van 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 25537466

  • Deathe 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 19479574

  • Jackson 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 19086706

  • Bolliger 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 29700477

  • Martinez-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 31281333

  • Franchignoni 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 15129398

  • Hordacre 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

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.

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