StrokePhase 1NCT00393926
Robot-Assisted Motivating Rehabilitation
A Phase 1 study testing TheraDrive Assistive Device and Rote Therapy versus Fun Therapy in people with Stroke and Cerebrovascular Accident, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- TheraDrive Assistive Device and Rote Therapy versus Fun Therapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2013
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be included in the study on the basis of the following criteria:
- They must be at least six months post-stroke.
- 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).
- They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone.
- They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.
- They report no excessive pain the impaired arm.
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- If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel.
- They must not be participating in any experimental rehabilitation or drug therapies.
- If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment.
- They must have driven prior to stroke.
- They are not clinically depressed (as measured by the Geriatric Depression Scale (GDS) short form (Sheikh and Yesavage, 1986).
Who cannot join
- Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
- Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.
- Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clement J Zablocki VA - Rehabilitation Robotics R&D Lab
Milwaukee, Wisconsin, 53295
About this study
Official title: Robot-Assisted Motivating Rehabilitation to Increase Upper Limb Function After Stroke
The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.
Read the detailed description
Typically, after brain damage due to a stroke, the affected arm is weak and suffering from some of paralysis. As a result, adults with this condition are unable to move their impaired arm well during their activities of daily living. Our research is focused on understanding how best to improve the ability of the arm to move after brain damage due to a stroke. We have implemented novel robot technology designed for eventual use as a home therapy device and have used software and hardware technologies to design activities that can assess the arm ability and engage the person during therapy. We will study how the prolong use of this device with simple, functional, and engaging activities improve the arm's movement ability and sustain motivation to use the arm over repeated therapy sessions and away from supervision.
Overall, we will establish whether using our technology to perform tasks that are more or less game-like and functionally relevant to driving will make a difference in the impaired arm after stroke. Two groups of stroke survivors will be followed while they complete therapy. We have three main aims. In aim #1, we will determine whether therapy using functional tasks compared to simple rote tasks lead to significant increases in the use of the arm during therapy and the arm improvements experienced by the subjects after the therapy. In aim #2, we will measure how each group engage in the more and less functional therapy and monitor their effort and enjoyment during training. This aim will help us to determine the value of more fun training. In aim #3, we will upgrade our technology for use in the home therapy environment and follow some subjects to determine if the results change in under supervised condition (at home)
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- TheraDrive Assistive Device, Rote Therapy versus Fun Therapy
- Keywords
- Robotics, Rehabilitation, Upper Extremity, CVA
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraDrive Assistive DeviceDevice
Rote Therapy versus Fun TherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Michelle J. Johnson, Medical College of Wisconsin
- Investigators
- Michelle J Johnson, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393926
- Sponsor's protocol ID
- 0635450Z
- Status last verified
- Feb 2014
- First submitted
- 30 Oct 2006
- Last updated
- 4 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Motivating Rehabilitation to Increase Upper Limb Function After Stroke
- ClinicalTrials.gov ID
- NCT00393926
- Acronym / sponsor ID
- 0635450Z
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- Robotics, Rehabilitation, Upper Extremity, CVA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Oct 2006 (estimated)
- 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.
The purpose of the study is to examine how a novel robot technology designed for eventual use as a home therapy can improve arm function after stroke.
Detailed description
Typically, after brain damage due to a stroke, the affected arm is weak and suffering from some of paralysis. As a result, adults with this condition are unable to move their impaired arm well during their activities of daily living. Our research is focused on understanding how best to improve the ability of the arm to move after brain damage due to a stroke. We have implemented novel robot technology designed for eventual use as a home therapy device and have used software and hardware technologies to design activities that can assess the arm ability and engage the person during therapy. We will study how the prolong use of this device with simple, functional, and engaging activities improve the arm's movement ability and sustain motivation to use the arm over repeated therapy sessions and away from supervision.
Overall, we will establish whether using our technology to perform tasks that are more or less game-like and functionally relevant to driving will make a difference in the impaired arm after stroke. Two groups of stroke survivors will be followed while they complete therapy. We have three main aims. In aim #1, we will determine whether therapy using functional tasks compared to simple rote tasks lead to significant increases in the use of the arm during therapy and the arm improvements experienced by the subjects after the therapy. In aim #2, we will measure how each group engage in the more and less functional therapy and monitor their effort and enjoyment during training. This aim will help us to determine the value of more fun training. In aim #3, we will upgrade our technology for use in the home therapy environment and follow some subjects to determine if the results change in under supervised condition (at home)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- They must be at least six months post-stroke.
- 18 years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert).
- They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone.
- They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes.
- They report no excessive pain the impaired arm.
Key exclusion criteria (3 listed)
- Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
- Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function.
- Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above inclusion criteria.
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 |
|---|---|---|
| TheraDrive Assistive Device | Device | – |
| Rote Therapy versus Fun Therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Michelle J Johnson, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TheraDrive Assistive Device and Rote Therapy versus Fun Therapy in people with Stroke and Cerebrovascular Accident, run by Medical College of Wisconsin 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 11 inclusion and 3 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: finished, as of the sponsor's last update on 4 Feb 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 4 Feb 2014.