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

NCT ID: NCT05652946

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2025-01-17

Brief Summary

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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

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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

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Neurologic Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Masked/blinded outpatient therapists will perform outcome assessments.

Study Groups

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Inpatient Rehabilitation with ART

Inpatient rehabilitation with advanced rehabilitation technology

Group Type EXPERIMENTAL

Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics

Intervention Type 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 without ART

Inpatient rehabilitation without advanced rehabilitation technology

Group Type ACTIVE_COMPARATOR

Standard inpatient rehabilitation therapy

Intervention Type OTHER

Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Interventions

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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

Intervention Type DEVICE

Standard inpatient rehabilitation therapy

Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Discovery Statistics

UNKNOWN

Sponsor Role collaborator

Rehabilitation Hospital of Overland Park

INDUSTRY

Sponsor Role lead

Responsible Party

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Brett Schoen

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brett Schoen, MD

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Hospital of Overland Park

Locations

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Rehabilitation Hospital of Overland Park

Overland Park, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeana R Young, AAS

Role: CONTACT

Phone: 913-967-5289

Email: [email protected]

Leslie R VanHiel, DScPT

Role: CONTACT

Phone: 404-226-8017

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 30269803 (View on PubMed)

Other Identifiers

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PH750

Identifier Type: -

Identifier Source: org_study_id