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

Neurologic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652946
• Other study ID #: PH750
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: January 17, 2025

Study information

• Verified date: December 2022
• Source: Rehabilitation Hospital of Overland Park
• Contact: Jeana R Young, AAS
• Phone: 913-967-5289
• Email: jyoung2[@]pamrehab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 17, 2025
• Est. primary completion date: October 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder

Intervention

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

Other:
• Standard inpatient rehabilitation therapy
Standard inpatient rehabilitation therapy without advanced rehabilitation technology

Locations

Country	Name	City	State
United States	Rehabilitation Hospital of Overland Park	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Rehabilitation Hospital of Overland Park	Discovery Statistics

Country where clinical trial is conducted

United States, 

References & 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. Erratum In: PM R. 2018 Dec;10(12):1437. — View Citation

Outcome

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