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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The six-minute walking test (6MWT)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •bilateral amputation,
- •the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.
结局指标
主要结局
The six-minute walking test (6MWT)
时间窗: through study completion, an average of one and a half months
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.
Visual Analogue Scale
时间窗: through study completion, an average of one and a half months
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)).
Short Form 36 (SF-36)
时间窗: through study completion, an average of one and a half months
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.
次要结局
- Likert scale(through study completion, an average of one and a half months)
研究者
Yasin Demir
Physical Medicine and Rehabilitation Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital