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

Rehabilitation Hospital of Overland Park

Status: Enrolling

Conditions: Neurologic Disorder

Treatments: Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics; Other: Standard inpatient rehabilitation therapy

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05652946

PH750

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Inpatient Rehabilitation with ART

Experimental group

Description:

Inpatient rehabilitation with advanced rehabilitation technology

Treatment:

Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics

Inpatient Rehabilitation without ART

Active Comparator group

Description:

Inpatient rehabilitation without advanced rehabilitation technology

Treatment:

Other: Standard inpatient rehabilitation therapy