Clinicians, Academics, Industry, and Insurance Collaborate to Assess Cost-Effectiveness and Functional Outcomes Using Advanced Rehabilitation Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neurologic Disorder
- Sponsor
- Rehabilitation Hospital of Overland Park
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Neuro-QOL
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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: 1. 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. 2. 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
Investigators
Brett Schoen
Medical Director
Rehabilitation Hospital of Overland Park
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Neuro-QOL
Time Frame: 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
Secondary Outcomes
- 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)