NCT05652946

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rehabilitation Hospital of Overland Park · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neurologic Disorder

Interventions

Type	Name	Description
DEVICE	Tyromotion, 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
OTHER	Standard inpatient rehabilitation therapy	Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-10-17
• Completion: 2025-01-17
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study