Lower Limb AmputationAmputationNCT06903637
Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation
An observational study of Lower Limb Amputation, run by Cigdem Cinar at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Hierarchical Cluster Analysis
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with lower limb amputation
Who may be able to join
- 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.
Who cannot join
- being unable to complete the study,
- having a history of severe psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lower Limb Amputation
- Being tested
- Hierarchical Cluster Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hierarchical Cluster AnalysisOther
Also called Houghton Scale, Timed Up and Go Test, rinity Amputation and Prosthesis Experience Scales, 12-item Short Form Health Survey
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2025
- Study start23 Dec 2023
- Primary completion23 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cigdem Cinar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cigdem Cinar, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903637
- Sponsor's protocol ID
- 2015-KAEK-80-23-45
- Acronym
- Amputation
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 31 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.''
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.
PubMed 32037876
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Rehabilitation for Lower Limb Amputation: the Role of Hierarchical Cluster Analysis in Identifying Priority Clinical Variables
- ClinicalTrials.gov ID
- NCT06903637
- Acronym / sponsor ID
- Amputation / 2015-KAEK-80-23-45
- Conditions
- Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cigdem CinarUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 31 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with lower limb amputation
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- being unable to complete the study,
- having a history of severe psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hierarchical Cluster AnalysisAlso: Houghton Scale, Timed Up and Go Test, rinity Amputation and Prosthesis Experience Scales, 12-item Short Form Health SurveyThe 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 | – |
Primary outcome
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)
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
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
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
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2025.
- Results publication: PubMed 32037876Wade 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.
- Individual participant dataSharing planned: Yes. 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.''
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation, run by Cigdem Cinar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Houghton Scale (time frame: 10 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2025.