HemiparesisNCT01651533
Mental Practice in Chronic, Stroke Induced Hemiparesis
A study testing Mental Practice Group in people with Hemiparesis, run by Ohio State University at 2 sites in United States.
Trial summary
Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Mental Practice Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Dec 2016
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a Fugl-Meyer score > 27, which is indicative of minimal to moderate arm impairment;
- stroke experienced > 6 months prior to study enrollment;
- minimal cognitive impairment, a score > 25 on the Folstein Mini Mental Status Examination (MMSE);
- age > 21 years old and < 80 years old;
- have experienced one clinical stroke as verified by a physician;
- discharged from all forms of physical rehabilitation targeting the affected arm.
Who cannot join
- < 21 years old;
- excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale;
- excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of greater than or equal to 2 on the Modified Ashworth Spasticity Scale;
- currently participating in any experimental rehabilitation or drug studies targeting UE;
- mirrors movements(i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand during attempts at unilateral movement by the stroke-affected hand);
- history of parietal stroke (because some data suggest that ability to estimate manual motor performance through mental imagery is disturbed after parietal lobe damage);
- affected arm joint restriction that in the opinion of the investigator would hinder study participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Metrohealth
Cleveland, Ohio
The Ohio State University
Columbus, Ohio
About this study
Official title: Mental Practice in Chronic, Stroke-Induced Hemiparesis
Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.
- Conditions
- Hemiparesis
- Being tested
- Mental Practice Group, Active Control Group
- Keywords
- Mental practice group, Active control group
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Practice GroupBehavioural
Patients are administered rehabilitative therapy targeting their affected arms on 3 days/week during a ten week period. Directly after the therapy session, they participate in targeted mental practice session in which they cognitively rehearse the movement that they just physically practiced.
Active Control GroupBehavioural
Individuals assigned to this group are administrated rehabilitative therapy targeting their affected arms in half four increments, occurring 3 days/week for 10 weeks. They also are administered an intervention in which they listen to a relaxation tape and/or tapes in which they receive instructions on exercises and information on stroke care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Mental Practice Group | Experimental | Not described Receives: Behavioral: Mental Practice Group |
| Active Comparator: Active Control Group | Active comparator | Not described Receives: Behavioral: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test
This is a measure that examines the participant's ability to use the affected wrist and fingers to grasp, pinch, and grip small objects (i.e., fine motor skills). Gross movements(e.g., touching the top of the head using the affected arm) are also briefly examined. The investigator will measure changes in these abilities. We will do this by administering the measure before and after participation in the study to determine if a change occurred in patients' movement abilities.
Measured: 2-3 weeks before intervention; 1 week after intervention; 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2016
- Study completionDec 2016
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 Ohio State 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Page, PhD,M.S., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651533
- Sponsor's protocol ID
- 2011H0216
- Status last verified
- Feb 2022
- First submitted
- 23 Jul 2012
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Practice in Chronic, Stroke-Induced Hemiparesis
- ClinicalTrials.gov ID
- NCT01651533
- Acronym / sponsor ID
- 2011H0216
- Conditions
- Hemiparesis
- Keywords
- Mental practice group, Active control group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jul 2012 (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.
Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mental Practice Group | Experimental | Behavioral: Mental Practice Group |
| Active Comparator: Active Control Group | Active comparator | Behavioral: Active Control Group |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a Fugl-Meyer score > 27, which is indicative of minimal to moderate arm impairment;
- stroke experienced > 6 months prior to study enrollment;
- minimal cognitive impairment, a score > 25 on the Folstein Mini Mental Status Examination (MMSE);
- age > 21 years old and < 80 years old;
- have experienced one clinical stroke as verified by a physician;
Key exclusion criteria (7 listed)
- < 21 years old;
- excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale;
- excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of greater than or equal to 2 on the Modified Ashworth Spasticity Scale;
- currently participating in any experimental rehabilitation or drug studies targeting UE;
- mirrors movements(i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand during attempts at unilateral movement by the stroke-affected hand);
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 Practice GroupPatients are administered rehabilitative therapy targeting their affected arms on 3 days/week during a ten week period. Directly after the therapy session, they participate in targeted mental practice session in which they cognitively rehearse the movement that they just physically practiced. | Behavioural | Experimental: Mental Practice Group |
| Active Control GroupIndividuals assigned to this group are administrated rehabilitative therapy targeting their affected arms in half four increments, occurring 3 days/week for 10 weeks. They also are administered an intervention in which they listen to a relaxation tape and/or tapes in which they receive instructions on exercises and information on stroke care. | Behavioural | Active Comparator: Active Control Group |
Primary outcome
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test
Time frame: 2-3 weeks before intervention; 1 week after intervention; 3 months after intervention
This is a measure that examines the participant's ability to use the affected wrist and fingers to grasp, pinch, and grip small objects (i.e., fine motor skills). Gross movements(e.g., touching the top of the head using the affected arm) are also briefly examined. The investigator will measure changes in these abilities. We will do this by administering the measure before and after participation in the study to determine if a change occurred in patients' movement abilities.
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 10 Feb 2022.
Related trials for Hemiparesis
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
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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.
Stephen Page, PhD,M.S. principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Practice Group in people with Hemiparesis, run by Ohio State University 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 6 inclusion and 7 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 10 Feb 2022. 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.
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?
Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test (time frame: 2-3 weeks before intervention; 1 week after intervention; 3 months after intervention). 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 10 Feb 2022.