Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation

NCT06903637 | Completed

• 1 other identifier: 2015-KAEK-80-23-45
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Limb Amputation

Outcome Measures

Primary Outcomes (7)

• Houghton Scale

  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)

  10 minutes

• Timed Up and Go (TUG) Test

  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

  5 minutes

• Trinity Amputation and Prosthesis Experience Scales

  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

  10 minutes

• Short-Form Health Survey score

  (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

  10 minutes

• The Locomotor Capabilities Index-5

  (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

  10 minutes

• Medicare Functional Classification Level

  (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)

  10 minutes

• Falls Efficacy Scale

  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

  10 minutes

Interventions

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.

Also known as: 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with lower limb amputation

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cigdem Cinar: lead

Study Sites (1)

Biruni University Hospital

Istanbul, 34295, Turkey (Türkiye)

Location

Related Publications (1)

• Wade DT. What is rehabilitation? An empirical investigation leading to an evidence-based description. Clin Rehabil. 2020 May;34(5):571-583. doi: 10.1177/0269215520905112. Epub 2020 Feb 10.

  PMID: 32037876 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor doctor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 31, 2025
• Study Start: December 23, 2023
• Primary Completion: December 23, 2024
• Study Completion: January 1, 2025
• Last Updated: March 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)