StrokePhase 1NCT00379392
Mental Imagery to Reduce Motor Deficits in Stroke
A Phase 1 study testing Mental Imagery only and Mental Imagery and Constraint induced therapy in people with Stroke, run by Emory University at 1 site in United States.
Trial summary
The primary aim of the proposed study is to collect data in an effort to estimate the clinical effectiveness of implementing repetitive task practice (RTP) in addition to mental imagery training (MIT) to improve upper extremity motor function and the quality of life of chronic stroke patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Mental Imagery only and Mental Imagery and Constraint induced therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Aug 2011
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum Motor Criteria Active wrist extension of no less than 10 degrees, 10 degrees of thumb abduction/extension and at least two additional digits. Must be able to perform at least 3 times in 1 minute.
- Passive Range of Motion At least 90 degrees of shoulder flexion and abduction, 45 degrees of shoulder external rotation, no less than -30 degrees of elbow extension, 45 degrees of forearm supination (from neutral), 45 degrees of forearm pronation (from neutral), wrist extension to neutral, finger extension (all digits) such that no MCP joint has greater than a 30 degree contracture.
- Participants who are 3-12 months post-stroke (first-time clinical CVA) of ischemic or hemorrhagic type at the beginning of the intervention.
- Participants with sensory loss will be eligible.
- Participants must score at least 24 on the MMSE. Memory deficits associated with dementia are the main concern with this inclusion criterion.
- Balance Criteria: Participants must be able to transfer to and from the toilet independently and safely, stand from a sitting position and maintain standing balance independently for at least two minutes with or without their own upper extremity support.
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- Each participant must have physician approval for participation in the therapy to rule out major medical problems.
- Participants must be over the age of 18 years. No upper age limits will be set.
- Participants must have sufficient endurance and stamina determined by clinical judgment to carry out the requirements of the CI therapy trial.
- Participants with unilateral perceptual neglect will be accepted if they meet the other inclusion criteria.
- Participants on medication will not be excluded. Subjects will be excluded if they have received Botox injections to their affected UE less than 3 months prior to participation, if they have received Phenol block injections less than 12 months prior to participation, if they are receiving intrathecal Baclofen, or if they are receiving Baclofen or Dantrium orally at the time of the study.
- Transportation to and from Emory Center for Rehabilitation.
Who cannot join
- Score of less than 24 on the MMSE.
- A first stroke less than 3 months or more than 12 months prior to enrollment.
- Less than 18 years of age.
- Clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.).
- Serious uncontrolled medical conditions.
- Excessive pain in any joint or more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician.
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- Passive ROM less than 90 degrees of shoulder flexion and abduction, less than 45 degrees of shoulder external rotation, greater than 30 degree flexion contracture of elbow, less than 45 degrees of forearm supination and pronation from neutral, less than neutral wrist extension and greater than 30 degree flexion contracture of any MCP joint.
- Unable to stand independently for 2 minutes, transfer independently to and from the toilet or perform sit-to-stand.
- Have received injections of anti-spasticity drugs into upper extremity musculature within the past 3 months, or wish to have drugs injected in the foreseeable future.
- Receiving any anti-spasticity drugs orally at the time of expected participation.
- Received phenol injections less than 12 months prior to participation.
- Damage to the parietal area of the brain
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the proposed study is to collect data in an effort to estimate the clinical effectiveness of implementing repetitive task practice (RTP) in addition to mental imagery training (MIT) to improve upper extremity motor function and the quality of life of chronic stroke patients.
Read the detailed description
Stroke is the leading cause of chronic disability in the United States, and lack of upper limb motor control is a major contributor to stroke-related disability. Physical and occupational therapy treatments are most commonly used to reduce long-term disability. Unfortunately, little scientific evidence exists to best target patients for therapy, define when such therapies should be provided, or even to identify the best therapies themselves. A recent National Institutes of Health consensus panel decided that there were only three therapeutic techniques with supporting scientific evidence, and for only one of these techniques, constraint induced therapy, was there evidence from a randomized trial.
The imagination, probably our most under-utilized health resource, can be used to remember and recreate the past, develop insight into the present, influence physical health, improve creativity and inspiration, and anticipate possible futures. All of us have, to some extent, experienced the effects of the imagination on the body. In recent years, data have suggested that mental practice can improve the performance of motor skill behaviors. These studies have generally shown that healthy volunteers who train with their minds on a specific task usually show better performance compared with a those that did not practice, although less than those who train physically.
To date, only a few small attempts to use mental practice in rehabilitation have been tried. A study in subacute stroke patients comparing the possibility and effectiveness of a program that combined imagery and physical therapy with a program of physical therapy only, showed that combining the two therapies is a clinically feasible, cost-effective addition to therapy that may improve functional outcomes more than participation in physical therapy only. Thus, mental practice in physical rehabilitation offers a potential way to improve motor recovery after damage to the brain.
One approach to improve arm function among patients with stroke is intensive repetitive task practice (RTP). This treatment can take the form of functional training alone or also include other ways encouraged within constraint induced (CI) movement therapy. Repetitive activities often used in physical or occupational therapy may also improve health related quality of life. While intense treatment, such as CI therapy, to overcome arm impairment may prove to be helpful, such therapy is expensive because it relies on one-on-one interaction between the patient and rehabilitation therapist. New therapeutic treatments to help existing therapy that offer helpful and money saving alternatives must be developed to improve arm use, and also, stroke survivors' quality of life.
While RTP and mental imagery may be promising treatments, we do not clearly understand the changes that may occur in the brain's of patients who have had a stroke following any physical rehabilitation. A few studies using positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) measures have shown the blood flow changes in the brain during physical movement following CIT. If the way in which recovery of motor function after stroke were better understood, better decisions could be made regarding the best selection of specific treatment strategies.
The primary aim of the proposed study is to collect data in an effort to estimate the clinical effectiveness of implementing RTP in addition to mental imagery training (MIT) to improve upper extremity motor function and the quality of life of chronic stroke patients. One group in this study will be asked to "mentally rehearse" a series of upper limb functional motor tasks for one and a half hours per day (3-30 minute sessions), with the guidance of an audio tape, for a total of 21 hours over two weeks. Another group will undergo 10 days (6 hours per day) RTP with a licensed rehabilitation specialist as well as listen to the same MIT tape for one and a half hours per day (3-30 minute sessions. Motor function and quality of life will be measured on two occasions: before the intervention and immediately after the intervention. A unique aspect of this study will be to obtain the fMRI data on a subset of patients enrolled in each group. Everything involving this study will be done at the Center for Rehabilitation Medicine at Emory University School of Medicine and at the Emory University Hospital.
This study represents one of the first tries at using mental imagery in addition to a physical rehabilitation for the recovery of movement after stroke and, to our knowledge, the first try to use fMRI to look at changes in the brain after mental training. The results of this study may allow us to learn more about the relationship between rehabilitation and brain function after stroke, as well as confirm the idea that actual changes in the brain are related to improving movement in the body.
This study uses an new therapeutic method along with well accepted methods (RTP) in an effort to improve arm movement of patients who have had a stroke. A thorough approach will be used to determine how the use of mental imagery along with RTP can change movement of the arm and the quality of life of patients who have had a stroke using proven clinical tests to determine movement performance and patients' quality of life. Furthermore, precise brain functioning tests (i.e. fMRI) will be performed to better understand the actual changes that happen in the brain when stroke patients have improved movement in their arm.
Should the use of MIT and RTP be better than RTP or MIT alone, a many year randomized clinical trial would be suggested to determine the helpfulness of using mental imagery training with RTP to improve arm function and the quality of life of patients with stroke. The benefits of this would be reduced costs for arm rehabilitation among certain patients who have had strokes and a better way for rehabilitation centers to prescribe and provide therapy targeting the arm. Because of shorter lengths of stay and fewer number of therapy sessions allowed for in- and out-patient services for stroke survivors, the use of additional and different delivery systems, such as mental imagery, become very important.
- Conditions
- Stroke
- Being tested
- Mental Imagery only, Mental Imagery and Constraint induced therapy
- Keywords
- Stroke, Mental Imagery, Constraint Induced Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Imagery onlyBehavioural
Listening to an audio tape to enhance mental imagery of functional activities of the affected upper extremity
Mental Imagery and Constraint induced therapyProcedure or surgery
Listening to an audio tape to enhance mental imagery AND participation in constraint induced therapy
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery and CIT | Experimental | Mental Imagery and Constraint Induced Therapy Receives: Procedure: Mental Imagery and Constraint induced therapy |
| Mental Imagery only | Active comparator | Mental Imagery only Receives: Behavioral: Mental Imagery only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Fugl-Meyer Motor Assessment Test
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Movement Imagery Questionnaire
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Vividness of Movement Imagery Questionnaire
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Center for Epidemiologic Studies Depression scale
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Stroke Impact Scale
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Secondary outcomes (1)
Sirigu's break test
Measured: Pre-treatment, Post-treatment, and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJan 2003
- Primary completionJul 2008
- Study completionAug 2011
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 Emory UniversityThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Butler, PhD, Emory University
- Investigators
- Andrew J Butler, PhD, MPT, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379392
- Sponsor's protocol ID
- 338-2003
- Other IDs
- R21AT002138-03
- Status last verified
- Apr 2015
- First submitted
- 19 Sep 2006
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Imagery to Reduce Motor Deficits in Stroke
- ClinicalTrials.gov ID
- NCT00379392
- Acronym / sponsor ID
- 338-2003
- Conditions
- Stroke
- Keywords
- Stroke, Mental Imagery, Constraint Induced Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Sep 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 primary aim of the proposed study is to collect data in an effort to estimate the clinical effectiveness of implementing repetitive task practice (RTP) in addition to mental imagery training (MIT) to improve upper extremity motor function and the quality of life of chronic stroke patients.
Detailed description
Stroke is the leading cause of chronic disability in the United States, and lack of upper limb motor control is a major contributor to stroke-related disability. Physical and occupational therapy treatments are most commonly used to reduce long-term disability. Unfortunately, little scientific evidence exists to best target patients for therapy, define when such therapies should be provided, or even to identify the best therapies themselves. A recent National Institutes of Health consensus panel decided that there were only three therapeutic techniques with supporting scientific evidence, and for only one of these techniques, constraint induced therapy, was there evidence from a randomized trial.
The imagination, probably our most under-utilized health resource, can be used to remember and recreate the past, develop insight into the present, influence physical health, improve creativity and inspiration, and anticipate possible futures. All of us have, to some extent, experienced the effects of the imagination on the body. In recent years, data have suggested that mental practice can improve the performance of motor skill behaviors. These studies have generally shown that healthy volunteers who train with their minds on a specific task usually show better performance compared with a those that did not practice, although less than those who train physically.
To date, only a few small attempts to use mental practice in rehabilitation have been tried. A study in subacute stroke patients comparing the possibility and effectiveness of a program that combined imagery and physical therapy with a program of physical therapy only, showed that combining the two therapies is a clinically feasible, cost-effective addition to therapy that may improve functional outcomes more than participation in physical therapy only. Thus, mental practice in physical rehabilitation offers a potential way to improve motor recovery after damage to the brain.
One approach to improve arm function among patients with stroke is intensive repetitive task practice (RTP). This treatment can take the form of functional training alone or also include other ways encouraged within constraint induced (CI) movement therapy. Repetitive activities often used in physical or occupational therapy may also improve health related quality of life. While intense treatment, such as CI therapy, to overcome arm impairment may prove to be helpful, such therapy is expensive because it relies on one-on-one interaction between the patient and rehabilitation therapist. New therapeutic treatments to help existing therapy that offer helpful and money saving alternatives must be developed to improve arm use, and also, stroke survivors' quality of life.
While RTP and mental imagery may be promising treatments, we do not clearly understand the changes that may occur in the brain's of patients who have had a stroke following any physical rehabilitation. A few studies using positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) measures have shown the blood flow changes in the brain during physical movement following CIT. If the way in which recovery of motor function after stroke were better understood, better decisions could be made regarding the best selection of specific treatment strategies.
The primary aim of the proposed study is to collect data in an effort to estimate the clinical effectiveness of implementing RTP in addition to mental imagery training (MIT) to improve upper extremity motor function and the quality of life of chronic stroke patients. One group in this study will be asked to "mentally rehearse" a series of upper limb functional motor tasks for one and a half hours per day (3-30 minute sessions), with the guidance of an audio tape, for a total of 21 hours over two weeks. Another group will undergo 10 days (6 hours per day) RTP with a licensed rehabilitation specialist as well as listen to the same MIT tape for one and a half hours per day (3-30 minute sessions. Motor function and quality of life will be measured on two occasions: before the intervention and immediately after the intervention. A unique aspect of this study will be to obtain the fMRI data on a subset of patients enrolled in each group. Everything involving this study will be done at the Center for Rehabilitation Medicine at Emory University School of Medicine and at the Emory University Hospital.
This study represents one of the first tries at using mental imagery in addition to a physical rehabilitation for the recovery of movement after stroke and, to our knowledge, the first try to use fMRI to look at changes in the brain after mental training. The results of this study may allow us to learn more about the relationship between rehabilitation and brain function after stroke, as well as confirm the idea that actual changes in the brain are related to improving movement in the body.
This study uses an new therapeutic method along with well accepted methods (RTP) in an effort to improve arm movement of patients who have had a stroke. A thorough approach will be used to determine how the use of mental imagery along with RTP can change movement of the arm and the quality of life of patients who have had a stroke using proven clinical tests to determine movement performance and patients' quality of life. Furthermore, precise brain functioning tests (i.e. fMRI) will be performed to better understand the actual changes that happen in the brain when stroke patients have improved movement in their arm.
Should the use of MIT and RTP be better than RTP or MIT alone, a many year randomized clinical trial would be suggested to determine the helpfulness of using mental imagery training with RTP to improve arm function and the quality of life of patients with stroke. The benefits of this would be reduced costs for arm rehabilitation among certain patients who have had strokes and a better way for rehabilitation centers to prescribe and provide therapy targeting the arm. Because of shorter lengths of stay and fewer number of therapy sessions allowed for in- and out-patient services for stroke survivors, the use of additional and different delivery systems, such as mental imagery, become very important.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery and CIT | Experimental | Procedure: Mental Imagery and Constraint induced therapyMental Imagery and Constraint Induced Therapy |
| Mental Imagery only | Active comparator | Behavioral: Mental Imagery onlyMental Imagery only |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Minimum Motor Criteria Active wrist extension of no less than 10 degrees, 10 degrees of thumb abduction/extension and at least two additional digits. Must be able to perform at least 3 times in 1 minute.
- Passive Range of Motion At least 90 degrees of shoulder flexion and abduction, 45 degrees of shoulder external rotation, no less than -30 degrees of elbow extension, 45 degrees of forearm supination (from neutral), 45 degrees of forearm pronation (from neutral), wrist extension to neutral, finger extension (all digits) such that no MCP joint has greater than a 30 degree contracture.
- Participants who are 3-12 months post-stroke (first-time clinical CVA) of ischemic or hemorrhagic type at the beginning of the intervention.
- Participants with sensory loss will be eligible.
- Participants must score at least 24 on the MMSE. Memory deficits associated with dementia are the main concern with this inclusion criterion.
Key exclusion criteria (12 listed)
- Score of less than 24 on the MMSE.
- A first stroke less than 3 months or more than 12 months prior to enrollment.
- Less than 18 years of age.
- Clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.).
- Serious uncontrolled medical conditions.
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 |
|---|---|---|
| Mental Imagery onlyListening to an audio tape to enhance mental imagery of functional activities of the affected upper extremity | Behavioural | Mental Imagery only |
| Mental Imagery and Constraint induced therapyListening to an audio tape to enhance mental imagery AND participation in constraint induced therapy | Procedure or surgery | Mental Imagery and CIT |
Primary outcome
Wolf Motor Function Test
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
Fugl-Meyer Motor Assessment Test
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
Movement Imagery Questionnaire
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
Vividness of Movement Imagery Questionnaire
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
Center for Epidemiologic Studies Depression scale
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
Stroke Impact Scale
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
1 secondary outcome
Sirigu's break test
Time frame: Pre-treatment, Post-treatment, and 3 month follow-up
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 14 Apr 2015.
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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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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.
Andrew J Butler, PhD, MPT principal investigator
Emory University
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 Mental Imagery only and Mental Imagery and Constraint induced therapy in people with Stroke, run by Emory University 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 12 inclusion and 12 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 14 Apr 2015. 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.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: Pre-treatment, Post-treatment, and 3 month follow-up). The study lists 6 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 14 Apr 2015.