Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Participant Rated Ease of Use
研究概览
简要总结
The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 to 17 years old
- •Musculoskeletal pain (e.g. localized [back, limb], diffuse) not due to acute trauma (e.g. active sprain or fracture)
- •English Language Proficiency
排除标准
- •Significant cognitive impairment (e.g., brain injury)
- •Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
- •Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).
研究组 & 干预措施
Pain Rehabilitation Virtual Reality (PRVR)
Participants will complete VR in PT to engage participants in a series of immersive games customized to align with individual PT needs delivered over ~6-12 weeks or until clinician believes the patient is done with treatment. Patients in the PRVR arm will be given a structured HEP to practice prescribed exercises at home with integrated VR activities. PRVR participants will be allocated a VR headset for use in PT sessions and with HEP. VR will supplement treatment and be used in session (either in-person or telehealth) and at home as part of their prescribed treatment homework.
干预措施: Pain Rehabilitation Virtual Reality (PRVR) (Behavioral)
Standard Physiotherapy Rehabilitation (SPR)
Sessions are individually-tailored and based on the Guide to Physical Therapy Practice 3.0 consisting of 1) therapeutic exercise, 2) balance and proprioception, 3) strength training, and 4) use of modalities (e.g., heat/cold pack). Patients will be given a structured Home Exercise Program (HEP) with prescribed exercises for home. SPR participants will be allocated a VR headset for recreational use.
干预措施: Standard Physiotherapy Rehabilitation (SPR) (Behavioral)
结局指标
主要结局
Participant Rated Ease of Use
时间窗: End of treatment at 6-8 weeks, on average
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
VR Duration of Use Per Week
时间窗: Baseline to end of treatment across 6-8 weeks, on average
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
Participant Rated Enjoyment
时间窗: End of treatment at 6-8 weeks, on average
This outcome is to assess Feasibility, Acceptability, and Utility of VR.
次要结局
- Pain-related Fear and Avoidance(Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment)
- Physical Function: Lower Extremity(Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment)
- Physical Function: Upper Extremity(Baseline to end of treatment at 6-8 weeks, on average and at 3-months after end of treatment)
研究者
Laura E Simons
Professor
Stanford University