Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in range of motion, measured with a goniometer
研究概览
简要总结
The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.
详细描述
This is a prospective single center randomized trial comparing a traditional approach to physical therapy to a technology-enhanced approach following a burn. We hypothesize that with the implementation of a novel telerehabilitation program incorporating technology enhancement, range of motion and quality of life can be improved. To test the hypothesis in future grant applications, this pilot study will be used to determine feasibility, collect preliminary data, vet endpoints, and gain patient feedback. To achieve these necessary goals, we will compare two methods of supporting home performance of prescribed physical and occupational therapy: Standard (S): patients will be equipped with paper instructions for their physical therapy exercises; and Technology-Enhanced (TE) support: patients will be given paper instructions, set up with a habit and productivity application (Avocation) that gamifies tasks and tracks achievements, a Fitbit activity tracker, a logbook, and have virtual movement therapy once weekly with an exercise physiologist for a total of four weeks.
Specific Aim 1: To determine whether range of motion is altered with TE. Range of motion in the affected joint(s) will be measured by goniometry (self-reported by patient and measured by study staff in the clinic)
Specific Aim 2: To determine whether TE with prescribed movement affects scar, pain, and quality of life.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults: ≥18 to ≤79 years of age
- •Not participating in another interventional trial
- •Admitted to the Blocker Burn Unit for treatment of initial burn
- •Subject is able and willing to follow the protocol requirements
- •Burn wound / scar / contracture occurring across at least one joint.
- •Has regular access to smart phone, tablet, or computer with internet access.
排除标准
- •Any medical condition that, in the opinion of the investigator or physician, would place the subject at increased risk for participation.
- •Concurrent participation on another interventional clinical trial
- •History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
- •Patients without internet access.
研究组 & 干预措施
A Standard of Care group (SOC)
Participants will receive standard of care education by the physical or occupational therapist regarding performance of the prescribed movements prior to discharge. Participants will complete the study about 6 months after discharge.
干预措施: Tele-Rehabilitation (Other)
A Standard of Care group (SOC) combined with technology enhancement
Participants will receive standard of care education by the physical or occupational therapist regarding performance of the prescribed movements prior to discharge. Participants will undergo additional training in the use of a goniometer to measure range of motion at home and record the measurement once a week for 6 months. Participants will engage in 4 virtual sessions as well as wear a Fitbit
干预措施: Tele-Rehabilitation (Other)
结局指标
主要结局
Change in range of motion, measured with a goniometer
时间窗: Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint)
Patient will be asked to bend the affected joint, and the goniometer held next to the joint to measure the angle. The range of motion for the opposite joint will be measured as well.
次要结局
- Itch Scale(Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint))
- Patient and Observer Scar Assessment Scale v2.0(Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint))
- Scar Volume(Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint))
- Elasticity, color, temperature, trans epidermal water loss, and scar thickness(Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint))
- Post Interview(6 months (± 2 weeks) post discharge)
- Pain Visual Analog Scale (VAS) Score(Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint))
- Overall Activity(Months 2, 4, and 5 (+15 days, each timepoint) in addition to 1, 3, & 6 months after discharge.)
- Blood Flow(Prior to planned discharge or during first week post- discharge (Baseline), and at clinic visits approximately 1, 3, & 6 months after discharge (±15 days, each timepoint))