The PACT Trial - PAtient Centered Telerehabilitation: Effectiveness of Software-supported and Traditional Mirror Therapy in Patients With Phantom Limb Pain Following Lower Limb Amputation: Design of a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 105
- 主要终点
- Change in average intensity of phantom limb pain
研究概览
简要总结
The overall aim of this randomized controlled study is to investigate the effectiveness of mirror therapy supported by telerehabilitation on the intensity, duration and frequency of phantom limb pain and daily activities compared to traditional mirror therapy and sensomotor exercises without a mirror in patients following lower limb amputation.
详细描述
Up to 75% of patients after amputation of an arm or leg suffer from chronic phantom limb pain that still is perceived in the missing limb, leading to limitations in daily activities and quality of life. The treatment of phantom limb pain is still challenging. Despite many different pharmacological interventions, the outcomes on the longer-term are in many cases not satisfying. Alternative, non-pharmacological interventions, such as mirror therapy, are gaining increased recognition in the treatment of phantom limb pain. In this context, telerehabilitation plays an important role to support long-term self-management and autonomy of these patients.
In the developmental phase of the project, a user-centred design is applied. Patients as well as physical and occupational therapists are interviewed concerning their preferences and needs with respect to the design and content of the telerehabilitation. Additionally, two focus groups with each five participants will be conducted. Subsequently, a prototype of the telerehabilitation will be developed based on user preferences, available evidence, expert opinion and already existing systems. This prototype will be tested on its usability and technical performance in phase three using the thinking-aloud-method and data logging. Accordingly, a multicenter, randomized controlled trial will be conducted to evaluate the cost-effectiveness of the telerehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Lower limb amputation
- •At least since one week constant or intermittent phantom limb pain (PLP) with an average intensity of at least score 3 on the 11-point NRS and a minimum frequency of one episode of PLP per week.
- •Sufficient cognitive, communicative and motor functions to be able to use the telerehabilitation service, to concentrate for at least 15 minutes on the mirror image and to follow instructions and questionnaires; this is based on clinical judgment of recruiting physicians or therapists.
排除标准
- •Duration of inpatient rehabilitation not long enough to ensure the 4-week clinical intervention phase.
- •Bilateral amputation, severe co-morbidity (e.g. stroke) or pain affecting the intact limb; this prevents engagement in the prescribed exercise programs of the study.
- •Severe psychiatric disorders that preclude patients from participating in the trial.
- •Intensive course of mirror therapy in the past (> 6 treatments during the last three months).
结局指标
主要结局
Change in average intensity of phantom limb pain
时间窗: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Measurement instrument: 11-point NRS
Change in frequency of phantom limb pain
时间窗: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
Change in duration of phantom limb pain
时间窗: At baseline, 4 and 6 weeks following baseline and at 6 months follow-up
次要结局
- Change in pain related limitations in daily activities(At baseline, 4 and 6 weeks following baseline and at 6 months follow-up)
- Change in pain specific self-efficacy(At baseline, 4 and 6 weeks following baseline and at 6 months follow-up)
- Change in quality of life(At baseline, 4 and 6 weeks following baseline and at 6 months follow-up)
- Change in global perceived effect(At baseline, 4 and 6 weeks following baseline and at 6 months follow-up)
- Change in dimensions of phantom limb pain(At baseline, 4 and 6 weeks following baseline and at 6 months follow-up)