Neurologic DisorderNCT05652946
IISART (International Industry Society of Advanced Rehabilitation Technology) Advanced Rehabilitation Technology Study
A study testing Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics and Standard inpatient rehabilitation therapy in people with Neurologic Disorder, run by Rehabilitation Hospital of Overland Park at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics and Standard inpatient rehabilitation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2022to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rehabilitation Hospital of Overland Park
Overland Park, Kansas, 66207
About this study
Official title: 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.
Read the 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:
- 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.
- 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
- Neurologic Disorder
- Being tested
- Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics, Standard inpatient rehabilitation therapy
- Keywords
- Advanced Rehabilitation Technology, Therapeutic Device, Robotic Rehabilitation Research, Health Economics, Functional Outcomes
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO BionicsDevice
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
Standard inpatient rehabilitation therapyOther
Standard inpatient rehabilitation therapy without advanced rehabilitation technology
| Study group | Role | What they receive |
|---|---|---|
| Inpatient Rehabilitation with ART | Experimental | Inpatient rehabilitation with advanced rehabilitation technology Receives: Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics |
| Inpatient Rehabilitation without ART | Active comparator | Inpatient rehabilitation without advanced rehabilitation technology Receives: Other: Standard inpatient rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-QOL
Neuro-QOL battery: Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Positive Affect and Well-Being
Measured: Through study completion, an average of 2 years
Secondary outcomes (16)
Length of stay/# of visits
Length of stay/# of visits
Measured: Through study completion, an average of 2 years
Total cost of care (TCOC)
Total cost of care (TCOC)
Measured: Through study completion, an average of 2 years
Cost of caregiver burden
Cost of caregiver burden
Measured: Through study completion, an average of 2 years
Discharge disposition
Discharge disposition
Measured: Through study completion, an average of 2 years
Return to work/school/volunteer
Return to work/school/volunteer
Measured: Through study completion, an average of 2 years
Return to Recreation
Return to Recreation
Measured: Through study completion, an average of 2 years
Areas of pain
Visual analog scale for patient report of pain
Measured: Through study completion, an average of 2 years
Spasticity
Visual analog scale for patient report of spasticity
Measured: Through study completion, an average of 2 years
Section GG scores
Functional Abilities and Goals
Measured: Through study completion, an average of 2 years
10 Meter Walk Test
Gait speed
Measured: Through study completion, an average of 2 years
Functional Ambulation Category
Walking ability
Measured: Through study completion, an average of 2 years
Functional Reach
Functional balance
Measured: Through study completion, an average of 2 years
Tinetti-Fall Efficacy Scale
Patient confidence regarding falls
Measured: Through study completion, an average of 2 years
Manual muscle test (MMT)
To test strength of upper and lower extremities
Measured: Through study completion, an average of 2 years
Range of Motion (ROM)
To test range of motion of upper and lower extremity joints
Measured: Through study completion, an average of 2 years
Quick DASH (Disabilities of the Arm, Shoulder, and Hand)
Upper extremity function
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start17 Oct 2022
- Primary completion17 Oct 2024 (estimated)
- Study completion17 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital of Overland Park
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Discovery Statistics
- Responsible party
- Principal investigator, Brett Schoen, Rehabilitation Hospital of Overland Park
- Investigators
- Brett Schoen, MD, Principal investigator, Rehabilitation Hospital of Overland Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652946
- Sponsor's protocol ID
- PH750
- Status last verified
- Dec 2022
- First submitted
- 14 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 30269803
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicians, Academics, Industry, and Insurance Collaborate to Assess Cost-Effectiveness and Functional Outcomes Using Advanced Rehabilitation Technology
- ClinicalTrials.gov ID
- NCT05652946
- Acronym / sponsor ID
- PH750
- Conditions
- Neurologic Disorder
- Keywords
- Advanced Rehabilitation Technology, Therapeutic Device, Robotic Rehabilitation Research, Health Economics, Functional Outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rehabilitation Hospital of Overland ParkIndustry (pharma, biotech, devices)
- Collaborators
- Discovery Statistics
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 17 Oct 2024 (estimated)
- Study completion
- 17 Jan 2025 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One group receives inpatient rehabilitation with advanced rehabilitation technology and one group receives inpatient traditional rehabilitation without advanced rehabilitation technology.
| Arm | Type | Receives |
|---|---|---|
| Inpatient Rehabilitation with ART | Experimental | Device: Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO BionicsInpatient rehabilitation with advanced rehabilitation technology |
| Inpatient Rehabilitation without ART | Active comparator | Other: Standard inpatient rehabilitation therapyInpatient rehabilitation without advanced rehabilitation technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO BionicsParticipants 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 | Device | Inpatient Rehabilitation with ART |
| Standard inpatient rehabilitation therapyStandard inpatient rehabilitation therapy without advanced rehabilitation technology | Other | Inpatient Rehabilitation without ART |
Primary outcome
Neuro-QOL
Time frame: Through study completion, an average of 2 years
Neuro-QOL battery: Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, Positive Affect and Well-Being
16 secondary outcomes
Length of stay/# of visits
Time frame: Through study completion, an average of 2 years
Total cost of care (TCOC)
Time frame: Through study completion, an average of 2 years
Cost of caregiver burden
Time frame: Through study completion, an average of 2 years
Discharge disposition
Time frame: Through study completion, an average of 2 years
Return to work/school/volunteer
Time frame: Through study completion, an average of 2 years
Return to Recreation
Time frame: Through study completion, an average of 2 years
Areas of pain
Time frame: Through study completion, an average of 2 years
Spasticity
Time frame: Through study completion, an average of 2 years
Section GG scores
Time frame: Through study completion, an average of 2 years
10 Meter Walk Test
Time frame: Through study completion, an average of 2 years
Functional Ambulation Category
Time frame: Through study completion, an average of 2 years
Functional Reach
Time frame: Through study completion, an average of 2 years
Tinetti-Fall Efficacy Scale
Time frame: Through study completion, an average of 2 years
Manual muscle test (MMT)
Time frame: Through study completion, an average of 2 years
Range of Motion (ROM)
Time frame: Through study completion, an average of 2 years
Quick DASH (Disabilities of the Arm, Shoulder, and Hand)
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 30269803Spiess 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Schoen, MD principal investigator
Rehabilitation Hospital of Overland Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyromotion, Fourier Intelligence, Thera-Trainer, EKSO Bionics and Standard inpatient rehabilitation therapy in people with Neurologic Disorder, run by Rehabilitation Hospital of Overland Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeana R Young, AAS (913-967-5289 ext. 2095, jyoung2@pamrehab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-QOL (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.