Effects of Muscle Strength Training in Lower Limb Amputee Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- Changes in Funcionality
研究概览
简要总结
This study is a clinical trial that evaluates the best treatment option using a strength training protocol and an endurance training protocol in patients with lower limb amputations who use prostheses. The protocol consists of 6 weeks of strength training and 6 weeks of endurance training, with a 1-month washout period between the two.
详细描述
The assessments in this study focus primarily on strength, using a dynamometer and the 5 RM, functionality, using the AMP scale, mobility, using the TugTest, quality of life, using the WHOQOL-BREF, and perception of change, using the GROC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral lower limb amputation
- •Transtibial and/or transfemoral amputation
- •Prosthetized
- •Aged 18 to 75 years
- •Who sign the informed consent form
排除标准
- •That they are unable to complete the initial assessment
- •That they undergo further secondary training
结局指标
主要结局
Changes in Funcionality
时间窗: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
It is assessed using the TUG test, which requires patients to get up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down again. Patients will receive the following instructions: "Get up on the word 'go,' walk to the tape, turn around, walk back to the chair, and sit down."
Changes in quality of life
时间窗: day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.
It is assessed using a self-administered questionnaire called WHOQOL-BREF, which provides a profile of the person's perceived quality of life.
次要结局
- Changes in Maximum isometric muscle strength(day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.)
- Changes on Movility(day 1, day 18 (last day of week 6), day 1 (after the wash out) and day 24.)
- Change in Global percepcion of change(assessments were performed at the end each protocol. day 18 and day 24)
研究者
Gabriela Dell Elce
principal investigator
University of Gran Rosario