IISART (International Industry Society of Advanced Rehabilitation Technology) Advanced Rehabilitation Technology Study

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinicians, Academics, Industry, and Insurance Collaborate to Assess Cost-Effectiveness and Functional Outcomes Using Advanced Rehabilitation Technology

Conditions
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Neurologic Disorder

Intervention / Treatment
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* Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics
* Other: Standard inpatient rehabilitation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inpatient Rehabilitation with ART<br>Inpatient rehabilitation with advanced rehabilitation technology | Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics<br>* Participants to receive at least 5 sessions with advanced rehabilitation technology including at least one, or multiple, of the following devices: Amadeo, Diego, Myro, Arm Motus EMU, Pelma Motus, Tigo, Balo, EKSO NR. Sessions are 45 (+/- 5) minutes<br>|
| Active Comparator: Inpatient Rehabilitation without ART<br>Inpatient rehabilitation without advanced rehabilitation technology | Other: Standard inpatient rehabilitation therapy<br>* Standard inpatient rehabilitation therapy without advanced rehabilitation technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-QOL | Neuro-QOL battery: Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Positive Affect and Well-Being | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay/# of visits | Length of stay/# of visits | Through study completion, an average of 2 years | 
| Total cost of care (TCOC) | Total cost of care (TCOC) | Through study completion, an average of 2 years | 
| Cost of caregiver burden | Cost of caregiver burden | Through study completion, an average of 2 years | 
| Discharge disposition | Discharge disposition | Through study completion, an average of 2 years | 
| Return to work/school/volunteer | Return to work/school/volunteer | Through study completion, an average of 2 years | 
| Return to Recreation | Return to Recreation | Through study completion, an average of 2 years | 
| Areas of pain | Visual analog scale for patient report of pain | Through study completion, an average of 2 years | 
| Spasticity | Visual analog scale for patient report of spasticity | Through study completion, an average of 2 years | 
| Section GG scores | Functional Abilities and Goals | Through study completion, an average of 2 years | 
| 10 Meter Walk Test | Gait speed | Through study completion, an average of 2 years | 
| Functional Ambulation Category | Walking ability | Through study completion, an average of 2 years | 
| Functional Reach | Functional balance | Through study completion, an average of 2 years | 
| Tinetti-Fall Efficacy Scale | Patient confidence regarding falls | Through study completion, an average of 2 years | 
| Manual muscle test (MMT) | To test strength of upper and lower extremities | Through study completion, an average of 2 years | 
| Range of Motion (ROM) | To test range of motion of upper and lower extremity joints | Through study completion, an average of 2 years | 
| Quick DASH (Disabilities of the Arm, Shoulder, and Hand) | Upper extremity function | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Rehabilitation Technology, Therapeutic Device, Robotic Rehabilitation Research, Health Economics, Functional Outcomes