NCT00589368

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

6 years

First QC Date

December 24, 2007

Last Update Submit

October 5, 2012

Conditions

Keywords

Brain InfarctionpathologyphysiopathologypsychologyrehabilitationFingersGraspFunctional LateralityHandStrengthNeuronal PlasticityPsychomotor PerformanceBiomechanisTouchWeight-Bearing

Outcome Measures

Primary Outcomes (1)

  • 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.

    immediately post-intervention

Secondary Outcomes (1)

  • Timing and magnitude of motor unit recruitment as measured by quantitative EMG of the grasping and lifting muscles.

    immediately post-intervention

Study Arms (2)

1

stroke group

Behavioral: Transfer of grasp control across hands

2

control group

Behavioral: Transfer of grasp control across hands

Interventions

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

12

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rusk Institute of Rehabilitation Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Brain Infarction

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Preeti Raghavan, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Rehabilitation Medicine

Study Record Dates

First Submitted

December 24, 2007

First Posted

January 9, 2008

Study Start

May 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 8, 2012

Record last verified: 2012-10

Locations