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临床试验/NCT06903637
NCT06903637已完成不适用

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

Cigdem Cinar1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Trinity Amputation and Prosthesis Experience Scales

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

结局指标

主要结局

Trinity Amputation and Prosthesis Experience Scales

时间窗: 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

Houghton Scale

时间窗: 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)

Timed Up and Go (TUG) Test

时间窗: 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

Medicare Functional Classification Level

时间窗: 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)

Falls Efficacy Scale

时间窗: 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

Short-Form Health Survey score

时间窗: 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

The Locomotor Capabilities Index-5

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Cigdem Cinar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cigdem Cinar

Associate professor doctor

Biruni University

研究点 (1)

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