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

Not Applicable

Recruiting

• Conditions: Neurologic Disorder
• Interventions: Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics; Other: Standard inpatient rehabilitation therapy

• Registration Number: NCT05652946
• Lead Sponsor: Rehabilitation Hospital of Overland Park

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

Study Timeline

• Study Start: 2022-10-17
• Study First Submitted: 2022-11-14
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Primary Completion: 2024-10-17
• Study Completion: 2025-01-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatient Rehabilitation with ART	Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics	Inpatient rehabilitation with advanced rehabilitation technology
Inpatient Rehabilitation without ART	Standard inpatient rehabilitation therapy	Inpatient rehabilitation without advanced rehabilitation technology

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Manual muscle test (MMT)	Through study completion, an average of 2 years	To test strength of upper and lower extremities
Return to work/school/volunteer	Through study completion, an average of 2 years	Return to work/school/volunteer
Total cost of care (TCOC)	Through study completion, an average of 2 years	Total cost of care (TCOC)
Range of Motion (ROM)	Through study completion, an average of 2 years	To test range of motion of upper and lower extremity joints
Discharge disposition	Through study completion, an average of 2 years	Discharge disposition
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
10 Meter Walk Test	Through study completion, an average of 2 years	Gait speed
Functional Reach	Through study completion, an average of 2 years	Functional balance
Quick DASH (Disabilities of the Arm, Shoulder, and Hand)	Through study completion, an average of 2 years	Upper extremity function
Length of stay/# of visits	Through study completion, an average of 2 years	Length of stay/# of visits
Cost of caregiver burden	Through study completion, an average of 2 years	Cost of caregiver burden
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
Tinetti-Fall Efficacy Scale	Through study completion, an average of 2 years	Patient confidence regarding falls
Functional Ambulation Category	Through study completion, an average of 2 years	Walking ability

Trial Locations

Locations (1)

Rehabilitation Hospital of Overland Park; 🇺🇸 Overland Park, Kansas, United States