Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation

NCT ID: NCT06903637

Last Updated: 2025-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-23

Study Completion Date

2025-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lower Limb Amputation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Hierarchical Cluster Analysis

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.

Intervention Type OTHER

Other Intervention Names

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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

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cigdem Cinar

OTHER

Sponsor Role lead

Responsible Party

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Cigdem Cinar

Associate professor doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Biruni University Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32037876 (View on PubMed)

Other Identifiers

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2015-KAEK-80-23-45

Identifier Type: -

Identifier Source: org_study_id