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Completed

NCT Number: NCT06903637

Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation

Background: Identifying which variables influence the personalized rehabilitation of patients with lower limb amputation and understanding their interrelationships optimizes resource allocation. This study aims to identify priority variables that influence clinical follow-up using hierarchical cluster analysis (HCA).

Methods: Data on 26 variables were collected from 70 patients diagnosed with lower limb amputation; (age, gender, body mass index(BMI), marital status, education, occupation, smoking and alcohol use, amputation - level/duration/lateral/etiology, prosthesis type, type of additional prosthesis, Kellgren Lawrence Classification(KLC) - right/left knee, Houghton Scale(HS), Timed-Up&Go(TUG) Test, Trinity Amputation and Prosthesis Experience Scales(TAPES)-prosthesis satisfaction/psychosocial adjustment/activity limitation, Using the 12-item Short Form Health Questionnaire(SF-12)-physical score(PS)/mental score(MS), Locomotor Capabilities Index-5(LCI-5), Medicare Functional Classification Level(MFCL) and Falls Efficacy Scale(FES)). From the collected data, dendrograms were formed by using HCA with Ward linkage method.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University Hospital

Istanbul, 34295, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having been diagnosis of lower limb amputation,
  • sufficient perceptual acuity to complete the tasks,
  • no head injury within the last 2 years, and
  • being a native Turkish speaker.

Exclusion criteria

  • being unable to complete the study,
  • having a history of severe psychiatric illness.

Treatment and study plan

Hierarchical Cluster Analysis

Other

The complexity of clinical follow-up stems from the wide range of variables involved, such as physical performance, mobility, pain, psychological well-being, and prosthetic functionality. Therefore, developing methods to identify the most relevant and interrelated clinical variables is critical for enhancing patient management. To address this need, Hierarchical Cluster Analysis (HCA) offers a powerful multivariate statistical approach for detecting relationships among clinical variables.

Other names: Houghton Scale, Timed Up and Go Test, rinity Amputation and Prosthesis Experience Scales, 12-item Short Form Health Survey, Locomotor Capabilities Index-5, Medicare Functional Classification Level, Fall Efficacy Scale

Primary outcomes

  1. Houghton Scale

    Time frame: 10 minutes

    This tool categorizes walking ability among lower limb amputees: independent ambulation in the community (score ≥9), independent ambulation in the home or limited community (score 6-8), and limited ambulation in the home (score ≤5)

  2. Timed Up and Go (TUG) Test

    Time frame: 5 minutes

    This test assesses balance and fall risk. Performance categories were as follows: ≤10 seconds (normal mobility), ≤20 seconds (good mobility, can walk without assistance), ≤30 seconds (needs gait aid, cannot walk outside independently). A score of ≥14 seconds indicates a high fall risk

  3. Trinity Amputation and Prosthesis Experience Scales

    Time frame: 10 minutes

    TAPES is a 33-item self-reported questionnaire measuring psychosocial adaptation, activity restriction, and prosthetic satisfaction. The subscales include general adjustment, social adjustment, and adjustment to limitation, along with functional and aesthetic satisfaction

  4. Short-Form Health Survey score

    Time frame: 10 minutes

    (SF-12) is a 12-item, self-rated, health quality instrument and it was validated into many languages as well as for many diseases. It has eight domains represented with one or two questionnaire items; these domains are physical functioning, role participation with physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role participation with emotional health problems (role-emotional), and mental health. It consists of 12 items where two of the items are three-point Likert type, the others are five-point Likert type

  5. The Locomotor Capabilities Index-5

    Time frame: 10 minutes

    (LCI-5) is a 14-item questionnaire specifically designed to measure walking ability of lower-limb amputees. Two subscales emerge from this general construct; basic abilities (7 items) and advanced abilities (7 items). The items inquire about the ability to perform activities and the level of independence while performing these activities. Each of the 14 items is graded on a 4-point ordinal scale; 0 (not able to), 1 (yes, with help from other person), 2 (yes, with supervision) and 3 (yes, independently). The total LCI score is the sum of the item scores and can range from 0 (worst) to 42 (best). Similarly, subscale scores for basic and advanced capabilities with the prosthesis can range from 0 to 21

  6. Medicare Functional Classification Level

    Time frame: 10 minutes

    (MFCL) is a classification system that categorizes the ambulatory potential of patients with lower limb amputations according to their functional mobility. The classification ranges from K0 (no prosthetic potential) to K4 (high functional potential for advanced physical activities)

  7. Falls Efficacy Scale

    Time frame: 10 minutes

    FES is a test used to assess participants' fear of falling and confidence in performing daily activities without falling. It is a 10-item self-report questionnaire that assesses perceived confidence in performing activities of daily living (e.g. dressing, bathing) without falling. Each item is scored on a 10-point Likert scale; 1 = very confident and 10 = not confident at all, with higher scores indicating greater fear of falling and lower self-efficacy. The total score ranges from 10 to 100

Sponsors and collaborators

Lead sponsor

Cigdem Cinar

Other

Registry information

Official study title

Personalized Rehabilitation for Lower Limb Amputation: the Role of Hierarchical Cluster Analysis in Identifying Priority Clinical Variables

Acronym: Amputation

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 31, 2025
Registry last updated
Mar 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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