NCT06827119

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

February 3, 2025

Last Update Submit

February 13, 2025

Conditions

Amputees / Rehabilitation

Keywords

EarthquakeAmputeesGait AnalysisBalance

Outcome Measures

Primary Outcomes (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.

    Assessed at a single study visit during the 12-month study period.

Other Outcomes (16)

  • Body Mass Index (BMI):

    Assessed at a single study visit during the 12-month study period.

  • Joint Range of Motion (ROM):

    Assessed at a single study visit during the 12-month study period.

  • Manuel muscle test

    Assessed at a single study visit during the 12-month study period.

  • +13 more other outcomes

Study Arms (1)

Cases

Earthquake survivor amputees

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People admitted to Ankara Bilkent City Hospital

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06690, Turkey (Türkiye)

Location

Related Publications (19)

  • 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.

    PMID: 30112982BACKGROUND

  • 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.

    PMID: 25785790BACKGROUND

  • 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.

    PMID: 34970628BACKGROUND

  • 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.

    PMID: 29706762BACKGROUND

  • 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.

    PMID: 30207875BACKGROUND

  • 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.

    PMID: 25003155BACKGROUND

  • 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.

    PMID: 19675123BACKGROUND

  • 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.

    PMID: 18489806BACKGROUND

  • 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.

    PMID: 25537466BACKGROUND

  • 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.

    PMID: 19479574BACKGROUND

  • 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.

    PMID: 19086706BACKGROUND

  • 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.

    PMID: 29700477BACKGROUND

  • 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.

    PMID: 31281333BACKGROUND

  • 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.

    PMID: 15129398BACKGROUND

  • 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.

    PMID: 22674875BACKGROUND

  • Hamamura S, Chin T, Kuroda R, Akisue T, Iguchi T, Kohno H, Kitagawa A, Tsumura N, Kurosaka M. Factors affecting prosthetic rehabilitation outcomes in amputees of age 60 years and over. J Int Med Res. 2009 Nov-Dec;37(6):1921-7. doi: 10.1177/147323000903700630.

    PMID: 20146892BACKGROUND

  • Fajardo-Martos I, Roda O, Zambudio-Periago R, Bueno-Cavanillas A, Hita-Contreras F, Sanchez-Montesinos I. Predicting successful prosthetic rehabilitation in major lower-limb amputation patients: a 15-year retrospective cohort study. Braz J Phys Ther. 2018 May-Jun;22(3):205-214. doi: 10.1016/j.bjpt.2017.08.002. Epub 2017 Nov 7.

    PMID: 29157737BACKGROUND

  • Hussain E, Kalaycioglu S, Milliner CWD, Cakir Z. Preconditioning the 2023 Kahramanmaras (Turkiye) earthquake disaster. Nat Rev Earth Environ. 2023;4(5):287-289. doi: 10.1038/s43017-023-00411-2. Epub 2023 Apr 24.

    PMID: 37168360BACKGROUND

  • McDonald CL, Westcott-McCoy S, Weaver MR, Haagsma J, Kartin D. Global prevalence of traumatic non-fatal limb amputation. Prosthet Orthot Int. 2021 Apr 1;45(2):105-114. doi: 10.1177/0309364620972258.

    PMID: 33274665BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 14, 2025

Study Start

July 19, 2023

Primary Completion

July 19, 2024

Study Completion

July 19, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

TU(1)