Clinical trial NCT05652946: IISART (International Industry Society of Advanced Rehabilitation Technology) Advanced Rehabilitation Technology Study
Official title: Clinicians, Academics, Industry, and Insurance Collaborate to Assess Cost-Effectiveness and Functional Outcomes Using Advanced Rehabilitation Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurologic Disorder
Keywords: Advanced Rehabilitation Technology
Therapeutic Device
Robotic Rehabilitation Research
Health Economics
Functional Outcomes
Lead sponsor: Rehabilitation Hospital of Overland Park
Sponsor class: INDUSTRY
Collaborators: name: Discovery Statistics
First posted: 2022-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Neuro-QOL
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Length of stay/# of visits
timeFrame: Through study completion, an average of 2 years
measure: Total cost of care (TCOC)
timeFrame: Through study completion, an average of 2 years
measure: Cost of caregiver burden
timeFrame: Through study completion, an average of 2 years
measure: Discharge disposition
timeFrame: Through study completion, an average of 2 years
measure: Return to work/school/volunteer
timeFrame: Through study completion, an average of 2 years
measure: Return to Recreation
timeFrame: Through study completion, an average of 2 years
measure: Areas of pain
timeFrame: Through study completion, an average of 2 years
measure: Spasticity
timeFrame: Through study completion, an average of 2 years
measure: Section GG scores
timeFrame: Through study completion, an average of 2 years
measure: 10 Meter Walk Test
timeFrame: Through study completion, an average of 2 years
measure: Functional Ambulation Category
timeFrame: Through study completion, an average of 2 years
measure: Functional Reach
timeFrame: Through study completion, an average of 2 years
measure: Tinetti-Fall Efficacy Scale
timeFrame: Through study completion, an average of 2 years
measure: Manual muscle test (MMT)
timeFrame: Through study completion, an average of 2 years
measure: Range of Motion (ROM)
timeFrame: Through study completion, an average of 2 years
measure: Quick DASH (Disabilities of the Arm, Shoulder, and Hand)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
measure: Goal attainment scale (GAS)
timeFrame: Through study completion, an average of 2 years
Locations:
city: Overland Park
country: United States
facility: Rehabilitation Hospital of Overland Park
state: Kansas
Study officials:
affiliation: Rehabilitation Hospital of Overland Park
name: Brett Schoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spiess MR, Steenbrink F, Esquenazi A. Getting the Best Out of Advanced Rehabilitation Technology for the Lower Limbs: Minding Motor Learning Principles. PM R. 2018 Sep;10(9 Suppl 2):S165-S173. doi: 10.1016/j.pmrj.2018.06.007.