Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation (Amputation)

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

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Other: Hierarchical Cluster Analysis

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34295
    • Biruni University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with lower limb amputation

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cigdem Cinar

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2023
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): March 31, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2015-KAEK-80-23-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The following data can be shared as individual participant data. These data were obtained by recording the clinical examination data of the patients in the questionnaire form (does not include personal data such as name, surname, telephone, address)

''Houghton Scale, Timed Up and Go Test, Trinity Amputation and Prosthesis Experience Scales (TAPES) - Prosthesis Satisfaction / Psychosocial Adjustment / Activity Restriction, 12-item Short Form Health Survey (SF-12) - Physical Score (PS) / Mental Score (MS), Locomotor Capabilities Index-5 (LCI-5), Medicare Functional Classification Level (K level), and Fall Efficacy Scale.''

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No