The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation

Study Overview
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Brief Summary
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Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data. Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.

Detailed Description
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Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data. Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation. Methods: Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Functional capacity will be evaluated using the six-minute walking test (6MWT). The severity of residual limb pain, sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale (VAS). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS. The QoL of each patient will be assessed using the Short Form 36 (SF-36).

Official Title
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The Effect of Using Two Different Prosthetic Feet on Functional Capacity, Pain Severity, Satisfaction Level and Quality of Life in High Activity Patients With Unilateral Transtibial Amputation

Conditions
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Amputation

Intervention / Treatment
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* Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-65 years Medicare functional classification level K4 (very active) using the prosthesis for at least 6 months and at least 6 hrs a day using active vacuum-assisted suspension system Exclusion Criteria: bilateral amputation, the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>21 patients using non-articulated dynamic foot (non-articulating ankle, NAA) | Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life<br>* The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life<br>|
| Group 2<br>21 patients using dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) | Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life<br>* The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | All patients will mark the severity of residual limb pain, sound limb pain and low back pain on a Visual Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)). | through study completion, an average of one and a half months | 
| Short Form 36 (SF-36) | The QoL of each patient will be assessed using the Short Form 36 (SF-36). The validity and reliability of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales that include physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores illustrate better QoL. | through study completion, an average of one and a half months | 
| The six-minute walking test (6MWT) | Functional capacity will be evaluated using the six-minute walking test (6MWT). The 6MWT evaluates walking function and endurance. Patients will be instructed to walk quickly, safely, and as much distance as possible along a rectangular path. The 6MWT is both valid and reliable among individuals with lower-limb loss. | through study completion, an average of one and a half months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scale | Level of difficulty experienced during walking on straight road, walking uneven road, ascending stairs, descending stairs, ascending ramps and descending ramps will be recorded on a 5-point Likert scale ((1) very easy, (2) easy , (3) neutral, (4) difficult, (5) very difficult). | through study completion, an average of one and a half months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transtibial amputation, Prosthetic foot, Functional capacity, Satisfaction, Quality of life