HemiparesisPhase 1NCT00878085
Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living
A Phase 1 study testing Robot Therapy Device and Occupational Therapy in people with Hemiparesis and Ischemic Stroke, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
The investigators will study motor recovery after robot-assisted therapy after stroke. A small clinical trial will be conducted to quantify the central nervous system changes associated with robotic or standard training, and identify trends across high and low responders in terms of patterns of change in cortical… Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiparesis, Ischemic Stroke, Chronic
- What is being tested?
- Robot Therapy Device and Occupational Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke:
- 30 to 85 years
- Right-handed (evaluated with handedness survey)
- suffered a unilateral ischemic stroke in the motor control area, which resulted in hemiparesis of the arm (confirmed by medical data),
- at least 6-months post-stroke
- residual movement at least (a) 15 degree shoulder flexion or adduction, (b) 15 degree active elbow flexion and extension
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- not claustrophobic
- not depressed (as measured depression survey)
- able to use the scanner, i.e., passes the fMRI screening survey
- able to understand the instructions and complete the tracking tasks Control
- older than 20 years
- Right-handed (evaluated with survey)
- not claustrophobic
- able to use the scanner, i.e., passes the fMRI screening survey
- able to understand the instructions and complete the tracking tasks
- no history of neurological disorders --not depressed (as measured depression survey)
Who cannot join
- Stroke:
- brain stem, stroke
- pre-existing neurological or psychiatric disorders
- Spasticity >3 at elbow or fingers on Ashworth
- demonstrated visuospatial, language or attention deficits of a severity that prevents understanding the task
- shoulder pain or joint pain during movements
Show all 16Show fewer
- synkinetic movements or mirror movements
- decline to participate
- will not comply with full protocol
- pregnant
- allergic to goretex and conductivity gel
- Control
- decline to participate
- will not comply with full protocol
- pregnant
- allergic to goretex and conductivity gel
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Clement J Zablocki VA
Milwaukee, Wisconsin, 53295
About this study
Official title: fMRI and Robot-Assisted Practice of Activities of Daily Living
The investigators will study motor recovery after robot-assisted therapy after stroke. A small clinical trial will be conducted to quantify the central nervous system changes associated with robotic or standard training, and identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity.The investigators hypothesize that robot training will lead to larger improvements as compared to standard occupational therapy. The investigators hypothesize that high responders to the robot training will have reduced compensatory activation in the bilateral area and will connectivity in the motor tracts.
Read the detailed description
Robot-assisted therapy is on the cutting edge of stroke rehabilitation and is a therapy method that promises to improve the lives of persons with disabilities due to stroke. Preliminary studies using these tools provide mixed evidence for their effectiveness and reveal limitations. For example, inconsistent carryover of motor gains to real life activities of daily living (ADLs) is seen. Therefore, it is still not clear what treatment strategies maximize functional outcomes on ADLs. There is a need to study the stroke recovery process and to understand how to optimize robot-assisted therapies in order to enhance patient rehabilitation and improve functional outcomes. Imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI) can assist us in understanding the stroke recovery process, in determining who may benefit from robot-assisted training, and in defining how training induced functional cortical changes occur after robot training. We propose to conduct an interventional study plus control to assess the effectiveness of four weeks of robot-assisted practice of tasks with skilled functional tasks that involve reaching and grasping activities similar to real activities. We will examine the process of recovery for low-to-moderate functioning stroke survivors with chronic disability. We will assess the ability of active-assisted reaching and grasping training to effect immediate gains and long-term functional improvements. Further, using fMRI and DTI, we plan to associate changes seen in motor impairment levels and functional task performance levels with white matter injuries and connectivity and changes in oxygen utilization in the motor cortex as well as other areas of the brain. Our short-term aims are to, i) assess short-term functional gains after practice of skilled reaching and grasping tasks; ii) assess maintenance of these improvements; iii) quantify the neuronal changes associated with short-term gains, and iv) identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity. In the long-term, we hope to improve understanding of the process of ADL functional recovery after stroke and optimize robot-training strategies leading to cerebral plasticity. We also hope to determine how lesion characteristics affect changes seen in function, white matter connectivity, and cortical activity. By, accomplishing these aims, we hope to improve upper extremity function after stroke and reduce disability.
- Conditions
- Hemiparesis, Ischemic Stroke, Chronic
- Being tested
- Robot Therapy Device, Occupational Therapy
- Keywords
- Robot Therapy, Upper Limb, Stroke, Rehabilitation, fMRI, DTI
- Medical subject headings
- Paresis, Ischemic Stroke, Bronchiolitis Obliterans Syndrome, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Therapy DeviceDevice
3x a week for 4 weeks
Occupational TherapyBehavioural
3x a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Robot Therapy with activities of daily living (ADLs) Receives: Device: Robot Therapy Device |
| 2 | Active comparator | Standard Occupational Therapy Receives: Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor
Measured: Pre (2x) , Post, Follow-Up
Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness
Measured: Pre (2x), Post, Follow-up
Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index
Measured: Pre (1x), Post, Follow-up
Secondary outcomes (2)
Clinical Measures: Joint ROM, MMT, Spasticity
Measured: Pre(2x), Post, Follow-up
Clinical Measures: Pain, Exertion
Measured: During Therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startNov 2008
- 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 HemiparesisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), US Department of Veterans Affairs, Marquette University
- Responsible party
- Principal investigator, Michelle J. Johnson, Medical College of Wisconsin
- Investigators
- Michel Torbey, MD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878085
- Sponsor's protocol ID
- HR
- Other IDs
- NIH 1K25NS058577 - 01A1
- Status last verified
- Feb 2014
- First submitted
- 23 Mar 2009
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- fMRI and Robot-Assisted Practice of Activities of Daily Living
- ClinicalTrials.gov ID
- NCT00878085
- Acronym / sponsor ID
- HR
- Conditions
- Hemiparesis, Ischemic Stroke, Chronic
- Keywords
- Robot Therapy, Upper Limb, Stroke, Rehabilitation, fMRI, DTI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), US Department of Veterans Affairs, Marquette University
- Study start
- Nov 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Apr 2009 (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 investigators will study motor recovery after robot-assisted therapy after stroke. A small clinical trial will be conducted to quantify the central nervous system changes associated with robotic or standard training, and identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity.The investigators hypothesize that robot training will lead to larger improvements as compared to standard occupational therapy. The investigators hypothesize that high responders to the robot training will have reduced compensatory activation in the bilateral area and will connectivity in the motor tracts.
Detailed description
Robot-assisted therapy is on the cutting edge of stroke rehabilitation and is a therapy method that promises to improve the lives of persons with disabilities due to stroke. Preliminary studies using these tools provide mixed evidence for their effectiveness and reveal limitations. For example, inconsistent carryover of motor gains to real life activities of daily living (ADLs) is seen. Therefore, it is still not clear what treatment strategies maximize functional outcomes on ADLs. There is a need to study the stroke recovery process and to understand how to optimize robot-assisted therapies in order to enhance patient rehabilitation and improve functional outcomes. Imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI) can assist us in understanding the stroke recovery process, in determining who may benefit from robot-assisted training, and in defining how training induced functional cortical changes occur after robot training. We propose to conduct an interventional study plus control to assess the effectiveness of four weeks of robot-assisted practice of tasks with skilled functional tasks that involve reaching and grasping activities similar to real activities. We will examine the process of recovery for low-to-moderate functioning stroke survivors with chronic disability. We will assess the ability of active-assisted reaching and grasping training to effect immediate gains and long-term functional improvements. Further, using fMRI and DTI, we plan to associate changes seen in motor impairment levels and functional task performance levels with white matter injuries and connectivity and changes in oxygen utilization in the motor cortex as well as other areas of the brain. Our short-term aims are to, i) assess short-term functional gains after practice of skilled reaching and grasping tasks; ii) assess maintenance of these improvements; iii) quantify the neuronal changes associated with short-term gains, and iv) identify trends across high and low responders in terms of patterns of change in cortical activity and type of white matter connectivity. In the long-term, we hope to improve understanding of the process of ADL functional recovery after stroke and optimize robot-training strategies leading to cerebral plasticity. We also hope to determine how lesion characteristics affect changes seen in function, white matter connectivity, and cortical activity. By, accomplishing these aims, we hope to improve upper extremity function after stroke and reduce disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Robot Therapy DeviceRobot Therapy with activities of daily living (ADLs) |
| 2 | Active comparator | Behavioral: Occupational TherapyStandard Occupational Therapy |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 30 to 85 years
- Right-handed (evaluated with handedness survey)
- suffered a unilateral ischemic stroke in the motor control area, which resulted in hemiparesis of the arm (confirmed by medical data),
- at least 6-months post-stroke
- residual movement at least (a) 15 degree shoulder flexion or adduction, (b) 15 degree active elbow flexion and extension
Key exclusion criteria (16 listed)
- brain stem, stroke
- pre-existing neurological or psychiatric disorders
- Spasticity >3 at elbow or fingers on Ashworth
- demonstrated visuospatial, language or attention deficits of a severity that prevents understanding the task
- shoulder pain or joint pain during movements
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 |
|---|---|---|
| Robot Therapy Device3x a week for 4 weeks | Device | 1 |
| Occupational Therapy3x a week for 4 weeks | Behavioural | 2 |
Primary outcome
Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor
Time frame: Pre (2x) , Post, Follow-Up
Biomechanical:Movement Time, Grasp Aperture, Movement Smoothness
Time frame: Pre (2x), Post, Follow-up
Imaging Measures: BOLD response (activation), Laterality Index, Fractional Anisotropy, Fiber Density Index
Time frame: Pre (1x), Post, Follow-up
2 secondary outcomes
Clinical Measures: Joint ROM, MMT, Spasticity
Time frame: Pre(2x), Post, Follow-up
Clinical Measures: Pain, Exertion
Time frame: During Therapy
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.
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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.
Michel Torbey, MD study chair
Medical College of Wisconsin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Robot Therapy Device and Occupational Therapy in people with Hemiparesis and Ischemic Stroke, run by Medical College of Wisconsin at 2 sites 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 16 inclusion and 16 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 2 sites 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.
What does the primary outcome measure?
Clinical Measures: Fugl-Meyer (Motor control), Functional Hand Evaluation (ADL), Jebsen Taylor (time frame: Pre (2x) , Post, Follow-Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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.