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

NCT05652946 | Unknown DMC FDA Device

• 1 other identifier: PH750
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder

Keywords

Advanced Rehabilitation Technology; Therapeutic Device; Robotic Rehabilitation Research; Health Economics; Functional Outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Length of stay/# of visits

  Through study completion, an average of 2 years

• Total cost of care (TCOC)

  Through study completion, an average of 2 years

• Cost of caregiver burden

  Through study completion, an average of 2 years

• Discharge disposition

  Through study completion, an average of 2 years

• Return to work/school/volunteer

  Through study completion, an average of 2 years

Other Outcomes (1)

• Goal attainment scale (GAS)

  Through study completion, an average of 2 years

Study Arms (2)

Inpatient Rehabilitation with ART

EXPERIMENTAL

Inpatient rehabilitation with advanced rehabilitation technology

Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics

Inpatient Rehabilitation without ART

ACTIVE COMPARATOR

Inpatient rehabilitation without advanced rehabilitation technology

Other: Standard inpatient rehabilitation therapy

Interventions

Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics DEVICE

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

Inpatient Rehabilitation with ART

Standard inpatient rehabilitation therapy OTHER

Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Inpatient Rehabilitation without ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehabilitation Hospital of Overland Park: lead
• Discovery Statistics: collaborator

Study Sites (1)

Rehabilitation Hospital of Overland Park

Overland Park, Kansas, 66207, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 30269803 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Brett Schoen, MD

  Rehabilitation Hospital of Overland Park

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeana R Young, AAS

CONTACT

913-967-5289; jyoung2@pamrehab.com

Leslie R VanHiel, DScPT

CONTACT

404-226-8017; leslie.vanhiel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked/blinded outpatient therapists will perform outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

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

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 15, 2022
• Study Start: October 17, 2022
• Primary Completion: October 17, 2024
• Study Completion: January 17, 2025
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)