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

Sponsor

Rehabilitation Hospital of Overland Park (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05652946

Collaborator

Discovery Statistics (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurologic Disorder	Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics Other: Standard inpatient rehabilitation therapy	N/A

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:

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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.

Masking:

Single (Outcomes Assessor)

Masking Description:

Masked/blinded outpatient therapists will perform outcome assessments.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

Oct 17, 2024

Anticipated Study Completion Date :

Jan 17, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inpatient Rehabilitation with ART Inpatient rehabilitation with advanced rehabilitation technology	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
Active Comparator: Inpatient Rehabilitation without ART Inpatient rehabilitation without advanced rehabilitation technology	Other: Standard inpatient rehabilitation therapy Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Arm

Intervention/Treatment

Experimental: Inpatient Rehabilitation with ART

Inpatient rehabilitation with advanced rehabilitation technology

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

Active Comparator: Inpatient Rehabilitation without ART

Inpatient rehabilitation without advanced rehabilitation technology

Other: Standard inpatient rehabilitation therapy

Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
Section GG scores [Through study completion, an average of 2 years]
Functional Abilities and Goals
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

Other Outcome Measures

Goal attainment scale (GAS) [Through study completion, an average of 2 years]
Patient report of goal setting

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Currently admitted for inpatient rehabilitation at Rehabilitation Hospital Overland Park with neurological diagnosis.
At least 18 years of age.
Predicted length of stay to be at least 7 days.
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.
Able to fit into at least one device.
Screened and cleared by a physician.
Cognitively intact to communicate pain and/or need to stop session, and able to follow simple commands.

Exclusion Criteria:

Current or history of other medical conditions that could affect the outcome measures.
Currently involved in another intervention study.
Any absolute contraindication listed for each device used.
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.