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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Disorder
• Intervention / Treatment: Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics; Other: Standard inpatient rehabilitation therapy

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeana R Young, AAS; Phone Number: 2095 913-967-5289; Email: jyoung2@pamrehab.com
• Study Contact Backup: Name: Leslie R VanHiel, DScPT; Phone Number: 404-226-8017; Email: leslie.vanhiel@gmail.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66207
      • Recruiting
      • Rehabilitation Hospital of Overland Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuro-QOL	Neuro-QOL battery: Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Positive Affect and Well-Being	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay/# of visits	Length of stay/# of visits	Through study completion, an average of 2 years
Total cost of care (TCOC)	Total cost of care (TCOC)	Through study completion, an average of 2 years
Cost of caregiver burden	Cost of caregiver burden	Through study completion, an average of 2 years
Discharge disposition	Discharge disposition	Through study completion, an average of 2 years
Return to work/school/volunteer	Return to work/school/volunteer	Through study completion, an average of 2 years
Return to Recreation	Return to Recreation	Through study completion, an average of 2 years
Areas of pain	Visual analog scale for patient report of pain	Through study completion, an average of 2 years
Spasticity	Visual analog scale for patient report of spasticity	Through study completion, an average of 2 years
Section GG scores	Functional Abilities and Goals	Through study completion, an average of 2 years
10 Meter Walk Test	Gait speed	Through study completion, an average of 2 years
Functional Ambulation Category	Walking ability	Through study completion, an average of 2 years
Functional Reach	Functional balance	Through study completion, an average of 2 years
Tinetti-Fall Efficacy Scale	Patient confidence regarding falls	Through study completion, an average of 2 years
Manual muscle test (MMT)	To test strength of upper and lower extremities	Through study completion, an average of 2 years
Range of Motion (ROM)	To test range of motion of upper and lower extremity joints	Through study completion, an average of 2 years
Quick DASH (Disabilities of the Arm, Shoulder, and Hand)	Upper extremity function	Through study completion, an average of 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal attainment scale (GAS)	Patient report of goal setting	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Rehabilitation Hospital of Overland Park
• Collaborators: Discovery Statistics
• Investigators: Principal Investigator: Brett Schoen, MD, Rehabilitation Hospital of Overland Park

Publications and helpful links

General Publications

• 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. Erratum In: PM R. 2018 Dec;10(12):1437.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Anticipated): October 17, 2024
• Study Completion (Anticipated): January 17, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Functional Outcomes; Advanced Rehabilitation Technology; Therapeutic Device; Robotic Rehabilitation Research; Health Economics
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: PH750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes