Transfer of Grasp Control Across Hands After Stroke - Full Text View

Sponsors and Collaborators:	Mount Sinai School of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00589368

Purpose

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.

Condition	Intervention
Stroke With Hemiparesis	Behavioral: Transfer of grasp control across hands

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Interhemispheric Transfer of Grasp Control After Stroke

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Timing and magnitude of motor unit recruitment as measured by quantitative EMG of the grasping and lifting muscles. [ Time Frame: immediately post-intervention ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	May 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 stroke group	Behavioral: Transfer of grasp control across hands 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
2 control group	Behavioral: Transfer of grasp control across hands 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

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.

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589368

Contacts

Contact: Preeti Raghavan, MD	212-241-9592	preeti.raghavan@mountsinai.org
Contact: Eddie Li	212-241-7182

Locations

United States, New York
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Principal Investigator: Preeti Raghavan, MD

Sponsors and Collaborators

Mount Sinai School of Medicine

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Preeti Raghavan, MD

Mount Sinai School of Medicine

More Information

No publications provided

Responsible Party:	Mount Sinai School of Medicine ( Preeti Raghavan, MD )
Study ID Numbers:	04-0585, K23 HD049472
Study First Received:	December 24, 2007
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00589368 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

Brain Infarction
pathology
physiopathology
psychology
rehabilitation
Fingers
Grasp
Functional Laterality

Hand
Strength
Neuronal Plasticity
Psychomotor Performance
Biomechanis
Touch
Weight-Bearing

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Paresis
Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Neurologic Manifestations
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Paresis
Nervous System Diseases
Stroke
Vascular Diseases

Central Nervous System Diseases
Neurologic Manifestations
Cardiovascular Diseases
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009