Feasibility and Functional Outcomes of a Novel Mixed Reality Based System to Manage Phantom Pain for Patients With Lower Limb Amputation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in Numerical Rating Scale
研究概览
简要总结
The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a sample of patients with lower limb amputation. Findings from this pilot study will serve as preliminary data to inform regarding a fully powered clinical trial to determine the effectiveness and practical implementation of these findings in real-world settings.
Aim1: Design and develop a feasible mixed reality based system to manage phantom pain in patients with lower limb amputation qualifying for on-going mirror therapy.
Hypothesis 1: The investigators hypothesize that the mixed reality based system to manage phantom pain will be feasible and well-received by a sample of patients with lower limb amputation needing mirror therapy.
Aim2: Evaluate functional outcomes in a sample of lower limb amputees (n=10), using this mixed reality based system to manage phantom pain.
Hypothesis 2: Using this system, the investigators hypothesize that patients who participate in the mixed reality based system will show improvements in functional mobility based on performance evaluations and patient reported outcome measures (PROs). The investigators also hypothesize that this mixed reality based system will help to alleviate the phantom pain based on McGill Pain questionnaire and visual analog scale (VAS).
详细描述
The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a sample of patients with lower limb amputation. Findings from this pilot study will serve as preliminary data to inform regarding a fully powered clinical trial to determine the effectiveness and practical implementation of these findings in real-world settings.
Aim1: Design and develop a feasible mixed reality based system to manage phantom pain in patients with lower limb amputation qualifying for on-going mirror therapy.
Hypothesis 1: The investigators hypothesize that the mixed reality based system to manage phantom pain will be feasible and well received by a sample of patients with lower limb amputation needing mirror therapy.
Aim2: Evaluate functional outcomes in a sample of lower limb amputees (n=10), using this mixed reality based system to manage phantom pain.
Hypothesis 2: Using this system, the investigators hypothesize that patients who participate in the mixed reality based system will show improvements in patient-reported outcome measures (PROs). The investigators also hypothesize that this mixed reality based system will help to alleviate the phantom pain based on Pain questionnaires and visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, over the age of 18 with lower limb amputations (greater than 3 months post surgery) with phantom limb pain
排除标准
- •Patients with lower limb amputations with open wounds or active infection in residual or contralateral limbs.
- •Patients with history of seizures.
- •Patients with visual (self-reported) or cognitive impairment (assessed by the mini-mental state examination) that interferes with ability to interact with, participate in, and adhere to a computerized rehabilitation system.
- •Any patient with a cardiac event in the last 6 months.
- •Any patient with an active medical issue to minimize risk of exacerbating their condition.
- •Lives more than 60 miles away from the Dallas VA Medical Center
- •Any patient with the motion sickness induced by head mounted displays (HMDs) or immersive environment.
- •Any patient experiencing the motion sickness induced by HMDs during the therapy session can also opt out of the study.
结局指标
主要结局
Change in Numerical Rating Scale
时间窗: baseline, 1-month
Pain intensity; 0-10; higher is worse
Change in McGill Pain Questionnaire
时间窗: baseline, 1-month
Pain intensity and interference; multiple scales; higher is worse. Range 0-78
次要结局
- Change in Patient Specific Functional Questionnaire(baseline, 1-month)
研究者
Thiru Annaswamy
Staff Physician and Professor
Dallas VA Medical Center