Stroke With HemiparesisNCT00589368
Transfer of Grasp Control Across Hands After Stroke
An observational study of Stroke With Hemiparesis, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to examine if the strong hand can assist in the recovery of muscle function in the weak hand after a stroke. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke With Hemiparesis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2012
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with stroke will be recruited from the inpatient and outpatient Rehabilitation units at the Mount Sinai Medical Center and from referrals by community rehabilitation physicians and neurologists. Control subjects will be recruited by public advertisement in the New York City area. There are no exclusions based on gender or ethnic groups.
Who may be able to join
- Previously right-handed subjects with hemiparesis and complaints of unilateral hand dysfunction during grasping resulting from a single unilateral cerebral infarct in the MCA territory affecting either the right or the left side of the brain at least 3 months prior to data collection
- Previously right-handed healthy control subjects age-matched to the stroke patients
- All subjects must have the ability to reach, grasp and lift the test object with both extremities (stroke patients with the impaired extremity as well) and complete the experimental protocol as assessed by the PI.
- All subjects must score > 24 on the Folstein's mini-mental exam to screen out significant cognitive dysfunction
- Subjects must obtain MRI or CT scan images of their brain taken since their stroke, or be willing to have a structural MRI or CT scan taken as part of this research study.
Who cannot join
- Presence of clinically significant visual deficits, aphasia, neglect, or apraxia as determined by clinical neurologic examination that may interfere with the research protocol
- Presence of sensory deficits in control subjects and in the non-involved hand of stroke subjects on testing of two-point discrimination
- History of surgery or other significant injury to the upper extremities
- Botulinum toxin injections in the upper extremity musculature in the three months prior to enrollment in the study.
- Current treatment with intrathecal baclofen
- Previous neurological illness such as head trauma, prior stroke, epilepsy, demyelinating disease
- Complicating medical problems such as uncontrolled, diabetes with polyneuropathy, severe renal, cardiac or pulmonary disease, or any other severe concurrent medical problem that will interfere with obtaining reliable results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rusk Institute of Rehabilitation Medicine
New York, New York, 10016
About this study
Official title: Interhemispheric Transfer of Grasp Control After Stroke
The purpose of this study is to examine if the strong hand can assist in the recovery of muscle function in the weak hand after a stroke.
Read the detailed description
Hemiparesis is the most common motor impairment after stroke. Persistent deficits in the distal upper extremity lead to impaired hand function and disability in Activities of Daily Living, accruing enormous costs in terms of health care services and lost productivity. The mechanisms of recovery of hand motor function after stroke are poorly understood, and the protocols used in clinical practice lack a solid scientific rationale. Prior work has shown that grasping with the non-involved hand may assist in planning of grasp with the involved hand after stroke. The goal of the proposed project is to investigate the type and nature of information relayed across the hemispheres by prior manipulation with the non-involved hand to improve planning and control of grasp with the involved hand. Psychophysical methods using a grip instrument will be used to examine the type of information necessary for planning of grasp, and quantitative surface electromyography will be used to investigate the contribution of improved planning to neuromuscular control of grasp. Integration of these methods in the study of grasp control will clarify the neural mechanisms underlying hand dysfunction, and facilitate the development of rational therapeutic protocols for upper extremity rehabilitation after stroke.
- Conditions
- Stroke With Hemiparesis
- Being tested
- Transfer of grasp control across hands
- Keywords
- Brain Infarction, pathology, physiopathology, psychology, rehabilitation, Fingers, Grasp, Functional Laterality, Hand, Strength, Neuronal Plasticity, Psychomotor Performance, Biomechanis, Touch, Weight-Bearing
- Medical subject headings
- Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer of grasp control across handsBehavioural
transfer of planning and execution of grasp across hands in terms of its effect on fingertip forces, and the timing and magnitude of muscle contraction in patients with hemiparesis and healthy controls
| Study group | Role | What they receive |
|---|---|---|
| 1 | stroke group Receives: Behavioral: Transfer of grasp control across hands | |
| 2 | control group Receives: Behavioral: Transfer of grasp control across hands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in peak load force rates for grasping a light and a heavy weight object as measured using a custom made object with 6 dof force sensors.
Measured: immediately post-intervention
Secondary outcomes (1)
Timing and magnitude of motor unit recruitment as measured by quantitative EMG of the grasping and lifting muscles.
Measured: immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startMay 2006
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke With HemiparesisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Preeti Raghavan, NYU Langone Health
- Investigators
- Preeti Raghavan, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589368
- Sponsor's protocol ID
- 04-0585
- Other IDs
- K23HD049472
- Status last verified
- Oct 2012
- First submitted
- 24 Dec 2007
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interhemispheric Transfer of Grasp Control After Stroke
- ClinicalTrials.gov ID
- NCT00589368
- Acronym / sponsor ID
- 04-0585
- Conditions
- Stroke With Hemiparesis
- Keywords
- Brain Infarction, pathology, physiopathology, psychology, rehabilitation, Fingers, Grasp, Functional Laterality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 9 Jan 2008 (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 this study is to examine if the strong hand can assist in the recovery of muscle function in the weak hand after a stroke.
Detailed description
Hemiparesis is the most common motor impairment after stroke. Persistent deficits in the distal upper extremity lead to impaired hand function and disability in Activities of Daily Living, accruing enormous costs in terms of health care services and lost productivity. The mechanisms of recovery of hand motor function after stroke are poorly understood, and the protocols used in clinical practice lack a solid scientific rationale. Prior work has shown that grasping with the non-involved hand may assist in planning of grasp with the involved hand after stroke. The goal of the proposed project is to investigate the type and nature of information relayed across the hemispheres by prior manipulation with the non-involved hand to improve planning and control of grasp with the involved hand. Psychophysical methods using a grip instrument will be used to examine the type of information necessary for planning of grasp, and quantitative surface electromyography will be used to investigate the contribution of improved planning to neuromuscular control of grasp. Integration of these methods in the study of grasp control will clarify the neural mechanisms underlying hand dysfunction, and facilitate the development of rational therapeutic protocols for upper extremity rehabilitation after stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Transfer of grasp control across handsstroke group |
| 2 | – | Behavioral: Transfer of grasp control across handscontrol group |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with stroke will be recruited from the inpatient and outpatient Rehabilitation units at the Mount Sinai Medical Center and from referrals by community rehabilitation physicians and neurologists. Control subjects will be recruited by public advertisement in the New York City area. There are no exclusions based on gender or ethnic groups.
Key inclusion criteria (5 listed)
- Previously right-handed subjects with hemiparesis and complaints of unilateral hand dysfunction during grasping resulting from a single unilateral cerebral infarct in the MCA territory affecting either the right or the left side of the brain at least 3 months prior to data collection
- Previously right-handed healthy control subjects age-matched to the stroke patients
- All subjects must have the ability to reach, grasp and lift the test object with both extremities (stroke patients with the impaired extremity as well) and complete the experimental protocol as assessed by the PI.
- All subjects must score > 24 on the Folstein's mini-mental exam to screen out significant cognitive dysfunction
- Subjects must obtain MRI or CT scan images of their brain taken since their stroke, or be willing to have a structural MRI or CT scan taken as part of this research study.
Key exclusion criteria (7 listed)
- Presence of clinically significant visual deficits, aphasia, neglect, or apraxia as determined by clinical neurologic examination that may interfere with the research protocol
- Presence of sensory deficits in control subjects and in the non-involved hand of stroke subjects on testing of two-point discrimination
- History of surgery or other significant injury to the upper extremities
- Botulinum toxin injections in the upper extremity musculature in the three months prior to enrollment in the study.
- Current treatment with intrathecal baclofen
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 |
|---|---|---|
| Transfer of grasp control across handstransfer of planning and execution of grasp across hands in terms of its effect on fingertip forces, and the timing and magnitude of muscle contraction in patients with hemiparesis and healthy controls | Behavioural | 1, 2 |
Primary outcome
Difference in peak load force rates for grasping a light and a heavy weight object as measured using a custom made object with 6 dof force sensors.
Time frame: immediately post-intervention
1 secondary outcome
Timing and magnitude of motor unit recruitment as measured by quantitative EMG of the grasping and lifting muscles.
Time frame: immediately post-intervention
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 8 Oct 2012.
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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.
Preeti Raghavan, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke With Hemiparesis, run by NYU Langone Health 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 5 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 8 Oct 2012. 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?
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?
Difference in peak load force rates for grasping a light and a heavy weight object as measured using a custom made object with 6 dof force sensors. (time frame: immediately post-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 8 Oct 2012.