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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00589368
Other study ID # 04-0585
Secondary ID K23HD049472
Status Completed
Phase N/A
First received December 24, 2007
Last updated October 5, 2012
Start date May 2006
Est. completion date May 2012

Study information

Verified date October 2012
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 90 Years
Eligibility Inclusion Criteria:

1. 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

2. Previously right-handed healthy control subjects age-matched to the stroke patients

3. 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.

4. All subjects must score > 24 on the Folstein's mini-mental exam to screen out significant cognitive dysfunction

5. 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:

1. Presence of clinically significant visual deficits, aphasia, neglect, or apraxia as determined by clinical neurologic examination that may interfere with the research protocol

2. Presence of sensory deficits in control subjects and in the non-involved hand of stroke subjects on testing of two-point discrimination

3. History of surgery or other significant injury to the upper extremities

4. Botulinum toxin injections in the upper extremity musculature in the three months prior to enrollment in the study.

5. Current treatment with intrathecal baclofen

6. Previous neurological illness such as head trauma, prior stroke, epilepsy, demyelinating disease

7. 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Rusk Institute of Rehabilitation Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University School of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Timing and magnitude of motor unit recruitment as measured by quantitative EMG of the grasping and lifting muscles. immediately post-intervention No
See also
  Status Clinical Trial Phase
Recruiting NCT02129491 - National Egyptian Network Pediatric Stroke and Hemiplegia Registry N/A
Completed NCT01586221 - Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke N/A
Terminated NCT01977027 - Strategies for Recovery of Dexterity Post Stroke N/A
Completed NCT01422161 - Study of Botulinum Toxin and Recovery of Hand Function After Stroke Phase 3