Clinicians, Academics, Industry, and Insurance Collaborate to Assess Cost-Effectiveness and Functional Outcomes Using Advanced Rehabilitation Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Neuro-QOL
研究概览
简要总结
A pre-post, randomized control trial comparing cost-effective and functional outcomes of participants with neurological diagnoses using robotic devices and advanced technology during inpatient rehabilitation to the outcomes of control participants without the use of robotic devices and advanced technology during rehabilitation. We aim to show at least similar inpatient rehabilitation outcomes and improved health economics in participants with neurological diagnoses by using robotic devices and advanced technology to increase the intensity and dose of rehabilitation.
详细描述
Many previous trials have shown equivalency of outcomes when comparing use of a robotic device vs standard therapy. Most often, the intensity was held equal between the two groups. However, robotic devices can greatly improve the intensity and dose of upper and lower extremity rehabilitation, while reducing therapist burden. Moreover, the outcome measures used in these previous studies were not specific to the task practiced in the device, or the task was not practiced outside of the device. This study provides robotic devices and advanced technology as part of the overall therapy plan and will include outcome measures based on individual participant return to community, in addition to health economic and functional measures. The rationale to use multiple robotic devices and advanced technology as part of rehabilitation is to improve quality of life/return to community as well as health economics and therapy outcomes.
Hypotheses:
- Assuming no difference in functional outcomes across groups, participants with neurological diagnoses receiving inpatient rehabilitation with robotic devices and advanced technology will show better quality of life/return to community and health economics outcomes (superiority hypothesis) compared to controls who do not receive rehabilitation with robotic devices or similar advanced technology.
- Participants with neurological diagnoses receiving inpatient rehabilitation with robotic devices and advanced technology will show functional outcomes at least as good as (non-inferiority hypothesis) those compared to controls who do not receive rehabilitation with robotic devices or similar advanced technology
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
- Single (Outcomes Assessor)
盲法说明
Masked/blinded outpatient therapists will perform outcome assessments.
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
- •Currently admitted for inpatient rehabilitation at Rehabilitation Hospital Overland Park with neurological diagnosis.
- •At least 18 years of age.
- •Predicted length of stay to be at least 7 days.
- •Able to tolerate upright sitting without orthostatic hypotension for upper extremity, cycling, and sitting balance devices AND/OR able to tolerate upright standing for at least 15 minutes without orthostatic hypotension for walking and standing balance devices.
- •Able to fit into at least one device.
- •Screened and cleared by a physician.
- •Cognitively intact to communicate pain and/or need to stop session, and able to follow simple commands.
排除标准
- •Current or history of other medical conditions that could affect the outcome measures.
- •Currently involved in another intervention study.
- •Any absolute contraindication listed for each device used.
- •Any pre-existing physical or medical condition that the Physiatrist determines would significantly limit a patient's ability to benefit from or continue in the study.
结局指标
主要结局
Neuro-QOL
时间窗: Through study completion, an average of 2 years
Neuro-QOL battery: Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Positive Affect and Well-Being
次要结局
- Manual muscle test (MMT)(Through study completion, an average of 2 years)
- Return to work/school/volunteer(Through study completion, an average of 2 years)
- Quick DASH (Disabilities of the Arm, Shoulder, and Hand)(Through study completion, an average of 2 years)
- Total cost of care (TCOC)(Through study completion, an average of 2 years)
- Range of Motion (ROM)(Through study completion, an average of 2 years)
- Discharge disposition(Through study completion, an average of 2 years)
- Return to Recreation(Through study completion, an average of 2 years)
- Areas of pain(Through study completion, an average of 2 years)
- 10 Meter Walk Test(Through study completion, an average of 2 years)
- Functional Reach(Through study completion, an average of 2 years)
- Length of stay/# of visits(Through study completion, an average of 2 years)
- Cost of caregiver burden(Through study completion, an average of 2 years)
- Spasticity(Through study completion, an average of 2 years)
- Section GG scores(Through study completion, an average of 2 years)
- Tinetti-Fall Efficacy Scale(Through study completion, an average of 2 years)
- Functional Ambulation Category(Through study completion, an average of 2 years)
研究者
Brett Schoen
Medical Director
Rehabilitation Hospital of Overland Park