Prosthetic Use, Mobility and Daily Functioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The Amputee Mobility Predictor (AMP).
研究概览
简要总结
The goal of the project is to explore which elements of rehabilitation that influence mobility in new and experienced unilateral lower-limb amputees.
详细描述
Both new and experienced unilateral lower limb amputees (LLA) describe difficulties when ambulating intentionally and independently from one place to another using prosthesis. In LLA, this decreased ability to mobilize affect daily functioning and may result in low activity-levels, impeded social participation and reduced health-related quality of life.
Both primary and secondary rehabilitation of LLA have implications for functional mobility. The consensus among health professionals is that LLA should train to improve their ability to ambulate. However, knowledge from research regarding which elements that constitute effective training and how systematic exercise affects body structures, functions, activity and participation in lower limb amputees, is limited.
There also is a lack of knowledge of how prosthetic users endure and process the challenges regarding mobility, how they adapt to the use of their prosthesis, how safe they are ambulating using the prosthesis, and how pain and psychosocial issues affect their perceived health and mobility.
The aim of this Ph.D.-project is to explore how a period of semi-standardized individualized rehabilitation originating from an evidence-based approach, affect the functional mobility of both new and experienced LLA, and how LLA process the loss of a limb and challenges during ambulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for experienced users of prosthesis - intervention group:
- •Unilaterally amputated (above the ankle joint / under the hip joint)
- •Minimum 12 months since amputation
- •Have a well-adapted prosthesis before baseline measurements
- •Not attended an organized, regular training program for the last 6 months
- •Uses the prosthesis on a daily basis
- •Participation approved by physician
- •Inclusion Criteria for experienced users of prosthesis - control group:
- •Unilaterally amputated (above the ankle joint / under the hip joint)
- •Minimum 12 months since amputation
- •Have a well-adapted prosthesis before baseline measurements
- •Daily use of the prosthesis
- •Not attended an organized, regular training program in the last 6 months
- •No participation in regular and systematic training between pre- and post-testing
- •Inclusion Criteria for new users of prosthesis:
- •Unilaterally amputated (above the ankle joint / under the hip joint)
- •No prior record of use of prosthesis
- •Participation approved by physician
排除标准
- •Bilaterally amputated over ankle joint
- •Lack of understanding of Norwegian language (oral, written)
- •Neurological disorders affecting gait function
- •Skin lesion or abrasion on the stump or remaining extremity affecting mobility and function
- •Other issues that complicate participation in a rehabilitation intervention
结局指标
主要结局
The Amputee Mobility Predictor (AMP).
时间窗: 4-8 weeks
The test is designed to measure mobility and ability to move with prosthesis (AMPPro) and without prosthesis (AMPNoPro). AMPPro provide a score range from 0-47. AMPNoPro provide a score range from 0-43. High scores indicate better outcome.
Prosthetic Limb Users Survey of Mobility (Plus-M) Short form - 12 items
时间窗: 4-8 weeks
A questionnaire that measures different aspects of mobility in lower-limb amputees (LLA) using prosthesis. PLUS-M provide a score range from 17.5 to 76.6. High scores indicate better outcome.
次要结局
未报告次要终点