Neurologic Disorder
Conditions
Keywords
Advanced Rehabilitation Technology, Therapeutic Device, Robotic Rehabilitation Research, Health Economics, Functional Outcomes
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
Interventions
DEVICETyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics
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
OTHERStandard inpatient rehabilitation therapy
Standard inpatient rehabilitation therapy without advanced rehabilitation technology
Sponsors
Discovery Statistics
Rehabilitation Hospital of Overland Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masked/blinded outpatient therapists will perform outcome assessments.
Intervention model description
One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Currently admitted for inpatient rehabilitation at Rehabilitation Hospital Overland Park with neurological diagnosis. 2. At least 18 years of age. 3. Predicted length of stay to be at least 7 days. 4. 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. 5. Able to fit into at least one device. 6. Screened and cleared by a physician. 7. Cognitively intact to communicate pain and/or need to stop session, and able to follow simple commands.
Exclusion criteria
1. Current or history of other medical conditions that could affect the outcome measures. 2. Currently involved in another intervention study. 3. Any absolute contraindication listed for each device used. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuro-QOL | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of stay/# of visits | Through study completion, an average of 2 years | Length of stay/# of visits |
| Total cost of care (TCOC) | Through study completion, an average of 2 years | Total cost of care (TCOC) |
| Cost of caregiver burden | Through study completion, an average of 2 years | Cost of caregiver burden |
| Discharge disposition | Through study completion, an average of 2 years | Discharge disposition |
| Return to work/school/volunteer | Through study completion, an average of 2 years | Return to work/school/volunteer |
| Return to Recreation | Through study completion, an average of 2 years | Return to Recreation |
| Areas of pain | Through study completion, an average of 2 years | Visual analog scale for patient report of pain |
| Spasticity | Through study completion, an average of 2 years | Visual analog scale for patient report of spasticity |
| 10 Meter Walk Test | Through study completion, an average of 2 years | Gait speed |
| Functional Ambulation Category | Through study completion, an average of 2 years | Walking ability |
| Functional Reach | Through study completion, an average of 2 years | Functional balance |
| Tinetti-Fall Efficacy Scale | Through study completion, an average of 2 years | Patient confidence regarding falls |
| Manual muscle test (MMT) | Through study completion, an average of 2 years | To test strength of upper and lower extremities |
| Range of Motion (ROM) | Through study completion, an average of 2 years | To test range of motion of upper and lower extremity joints |
| Quick DASH (Disabilities of the Arm, Shoulder, and Hand) | Through study completion, an average of 2 years | Upper extremity function |
| Section GG scores | Through study completion, an average of 2 years | Functional Abilities and Goals |
Other
| Measure | Time frame | Description |
|---|---|---|
| Goal attainment scale (GAS) | Through study completion, an average of 2 years | Patient report of goal setting |
Countries
United States
Contacts
Primary ContactJeana R Young, AAS
Backup ContactLeslie R VanHiel, DScPT
Outcome results
None listed