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CompletedNCT06827119Updated Feb 14, 2025

Relationship Between Prosthesis Adaptation and Functional Mobility

An observational study in Amputees / Rehabilitation, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-14.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
18
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Amputees / Rehabilitation

Keywords

  • Earthquake
  • Amputees
  • Gait Analysis
  • Balance
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People admitted to Ankara Bilkent City Hospital

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    Earthquake survivor amputees

06

What researchers measure

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.

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

Other outcomes

  1. Body Mass Index (BMI):

    A calculation based on weight and height to categorize individuals as underweight, normal weight, overweight, or obese.

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

  2. Joint Range of Motion (ROM):

    Measures the movement capability of a joint in degrees, assessing flexibility and any restrictions in motion.

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

  3. Manuel muscle test

    The manual muscle test (MMT) is a clinical method used to evaluate the strength of specific muscles or muscle groups. It involves applying resistance to a muscle's voluntary contraction and grading its performance based on strength and endurance.Typically scored on a 0-5 scale.

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

  4. Timed Up and Go Test (TUG)

    Evaluates functional mobility by measuring the time taken to stand up, walk 3 meters, turn, and return to the chair.

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

  5. 10-Meter Walk Test (10MWT)

    Assesses walking speed by timing a person walking a 10-meter distance.

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

  6. 2-Minute Walk Test (2MWT)

    Measures endurance by evaluating the distance walked in two minutes.

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

  7. Houghton Scale

    Evaluates prosthesis use and mobility in individuals with lower limb amputations.

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

  8. Locomotor Capabilities Index (LCI)

    A questionnaire that assesses functional mobility, especially in individuals with prosthetic limbs.

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

  9. Berg Balance Scale (BBS)

    A 14-item scale used to measure balance and risk of falling in individuals.

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

  10. Fear of Falling Visual Analog Scale

    A subjective measure of the fear of falling, rated on a 0-10 scale.

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

  11. Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0)

    A questionnaire evaluating user satisfaction with assistive devices in terms of performance and service quality.

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

  12. Center of Mass (COM) Assessment

    Analyzes body balance and stability by tracking COM movements on a specialized platform.

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

  13. Cadence Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess cadence (number of steps per minute)

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

  14. Double Support Percentage Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess the percentage of time both feet are in contact with the ground during walking

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

  15. Stride Length Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess the length of a single stride during walking.

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

  16. Step Width Measurement with Treadmill-Based Gait Analysis

    Uses treadmill equipment to assess the distance between the heels of the feet during walking

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

07

Study locations

1 site
  • Ankara Bilkent City Hospital
    Ankara, Çankaya 06690, Turkey
08

References and documents

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 ↗
  • 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. PubMed 20146892 ↗
  • 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. PubMed 29157737 ↗
  • 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. PubMed 37168360 ↗
  • 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. PubMed 33274665 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06827119
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Sponsor
First posted
Feb 14, 2025
Start date
Jul 19, 2023
Primary completion
Jul 19, 2024
Completion
Jul 19, 2024
Last update
Feb 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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