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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
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
Standard inpatient rehabilitation therapy without advanced rehabilitation technology
Rehabilitation Hospital of Overland Park
Overland Park, Kansas, United States
RECRUITINGNeuro-QOL
Neuro-QOL battery: Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Positive Affect and Well-Being
Time frame: Through study completion, an average of 2 years
Length of stay/# of visits
Length of stay/# of visits
Time frame: Through study completion, an average of 2 years
Total cost of care (TCOC)
Total cost of care (TCOC)
Time frame: Through study completion, an average of 2 years
Cost of caregiver burden
Cost of caregiver burden
Time frame: Through study completion, an average of 2 years
Discharge disposition
Discharge disposition
Time frame: Through study completion, an average of 2 years
Return to work/school/volunteer
Return to work/school/volunteer
Time frame: Through study completion, an average of 2 years
Return to Recreation
Return to Recreation
Time frame: Through study completion, an average of 2 years
Areas of pain
Visual analog scale for patient report of pain
Time frame: Through study completion, an average of 2 years
Spasticity
Visual analog scale for patient report of spasticity
Time frame: Through study completion, an average of 2 years
Section GG scores
Functional Abilities and Goals
Time frame: Through study completion, an average of 2 years
10 Meter Walk Test
Gait speed
Time frame: Through study completion, an average of 2 years
Functional Ambulation Category
Walking ability
Time frame: Through study completion, an average of 2 years
Functional Reach
Functional balance
Time frame: Through study completion, an average of 2 years
Tinetti-Fall Efficacy Scale
Patient confidence regarding falls
Time frame: Through study completion, an average of 2 years
Manual muscle test (MMT)
To test strength of upper and lower extremities
Time frame: Through study completion, an average of 2 years
Range of Motion (ROM)
To test range of motion of upper and lower extremity joints
Time frame: Through study completion, an average of 2 years
Quick DASH (Disabilities of the Arm, Shoulder, and Hand)
Upper extremity function
Time frame: Through study completion, an average of 2 years
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