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| Name | Class |
|---|---|
| Discovery Statistics | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient Rehabilitation with ART | Experimental | Inpatient rehabilitation with advanced rehabilitation technology |
|
| Inpatient Rehabilitation without ART | Active Comparator | Inpatient rehabilitation without advanced rehabilitation technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Goal attainment scale (GAS) | Patient report of goal setting | Through study completion, an average of 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeana R Young, AAS | Contact | 913-967-5289 | 2095 | jyoung2@pamrehab.com |
| Leslie R VanHiel, DScPT | Contact | 404-226-8017 | leslie.vanhiel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Brett Schoen, MD | Rehabilitation Hospital of Overland Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Hospital of Overland Park | Recruiting | Overland Park | Kansas | 66207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30269803 | Background | 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. |
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One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.
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Masked/blinded outpatient therapists will perform outcome assessments.
|
| Standard inpatient rehabilitation therapy | Other | Standard inpatient rehabilitation therapy without advanced rehabilitation technology |
|
| 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 |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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