Clinical trial NCT06827119: Relationship Between Prosthesis Adaptation and Functional Mobility
Official title: Investigation of the Relationship Between Lower Limb Prosthesis Usage Skills and Adaptation Level with Functional Mobility and Activities of Daily Living
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputees / Rehabilitation
Keywords: Earthquake
Amputees
Gait Analysis
Balance
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People admitted to Ankara Bilkent City Hospital

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: K level clasification
timeFrame: Assessed at a single study visit during the 12-month study period.
Secondary outcomes:
Other outcomes:
measure: Body Mass Index (BMI):
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Joint Range of Motion (ROM):
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Manuel muscle test
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Timed Up and Go Test (TUG)
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: 10-Meter Walk Test (10MWT)
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: 2-Minute Walk Test (2MWT)
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Houghton Scale
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Locomotor Capabilities Index (LCI)
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Berg Balance Scale (BBS)
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Fear of Falling Visual Analog Scale
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Center of Mass (COM) Assessment
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Cadence Measurement with Treadmill-Based Gait Analysis
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Double Support Percentage Measurement with Treadmill-Based Gait Analysis
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Stride Length Measurement with Treadmill-Based Gait Analysis
timeFrame: Assessed at a single study visit during the 12-month study period.
measure: Step Width Measurement with Treadmill-Based Gait Analysis
timeFrame: Assessed at a single study visit during the 12-month study period.
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.