The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation
NCT ID: NCT04759014
Last Updated: 2021-11-23
Study Results
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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COMPLETED
42 participants
OBSERVATIONAL
2021-02-18
2021-07-01
Brief Summary
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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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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).
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group 1
21 patients using non-articulated dynamic foot (non-articulating ankle, NAA)
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
Group 2
21 patients using dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA)
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
Interventions
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The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
Eligibility Criteria
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Inclusion Criteria
* 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
* the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.
18 Years
65 Years
ALL
No
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Yasin Demir
Physical Medicine and Rehabilitation Associate Professor
Principal Investigators
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Merve Orucu Atar, MD
Role: PRINCIPAL_INVESTIGATOR
Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
Locations
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Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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11
Identifier Type: -
Identifier Source: org_study_id