Study of the Recovery of Muscle Function in the Arm/Hand After a Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01422005
First received: August 19, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to examine if practicing joint movements using specially designed devices can help in the recovery of muscle function in the arm/hand after a stroke. Subjects may qualify for participation in this study because they had a stroke and have had difficulty using their affected arm/hand ever since.


Condition Intervention Phase
Stroke
Hemiparesis
Other: Simultaneous Bimanual training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Simultaneous Bimanual Training to Improve Motor Function Post-Stroke

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Measurement of hand function [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

    The outcome measures using the devices will include:

    • hand function
    • range of motion
    • stiffness
    • extent of impairment on the affected side
    • temperature differences between the two sides of the body, and
    • skin sensitivity to pressure.

    Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.



Secondary Outcome Measures:
  • Measurement of Hand Function [ Time Frame: Day 84 ] [ Designated as safety issue: No ]

    The outcome measures using the devices will include:

    • hand function
    • range of motion
    • stiffness
    • extent of impairment on the affected side
    • temperature differences between the two sides of the body, and
    • skin sensitivity to pressure.

    Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.



Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices.
Other: Simultaneous Bimanual training

Patients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices.

Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy.

Other Names:
  • Device group
  • Control group
Active Comparator: Control Group
Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.
Other: Simultaneous Bimanual training

Patients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices.

Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy.

Other Names:
  • Device group
  • Control group

Detailed Description:

Stroke is a leading cause of long-term adult disability in the United States, and hemiparesis is the most common motor impairment that frequently leads to persistent deficits in hand function. 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. The long-term objective of this research is to understand the neural mechanisms underlying the recovery of voluntary motor functions in brain-injured patients in order to provide a more objective and scientific basis to rehabilitation protocols used in clinical practice.

Dr. Preeti Raghavan and Dr. Donald Weisz, both research study doctors, are the named inventors of the devices being used in and investigated as part of this research study. These devices will be used to facilitate the training of either unimanual or bimanual movements that can be used both in the acute and chronic post-stroke period, even when there is little active movement in the affected upper extremity. The specially designed mechanical devices (BAT, PST and WIFIT), Psychophysical methods using an instrumented glove, and electromyographic recordings from upper extremity muscles to investigate the following specific aims in patients with post-stroke hemiparesis will lead to:

  • greater extensor muscle activation and out of synergy movement compared with unimanual training facilitated by an external agent (e.g. another person).
  • Bimanual training with the specially designed mechanical devices (BAT, PST and WIFIT) over 6 weeks will produce greater functional recovery in the affected upper extremity in patients with post-stroke hemiparesis, compared with conventional therapy.
  • The gains in motor control and function will be greater in patients who begin bimanual training in the acute post-stroke phase (0-6) months, compared with those that begin in the chronic post-stroke phase (> 6 months).
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to follow study instructions and likely to complete all required visits; ability to comply with the therapy protocol as assessed by the investigator; must be English speaking.
  • Subjects must have had a unilateral stroke

Exclusion Criteria:

  • Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
  • Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
  • Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
  • Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422005

Contacts
Contact: Preeti Raghavan, M.D 212.263.0344 preeti.raghavan@nyumc.org
Contact: Zena Moore, BA 212.263.0344 zena.moore@nyumc.org

Locations
United States, New York
New York Univeristy School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Preeti Raghavan, M.D.    212-263-0344    preeti.raghavan@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
Mount Sinai School of Medicine
Investigators
Principal Investigator: Preeti Raghavan, MD New York Univeristy School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01422005     History of Changes
Other Study ID Numbers: 11-00118, R#: 11-00118
Study First Received: August 19, 2011
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Rehabilitation
Fingers
Grasp
Hand
Strength
Brain Infraction
Hand Function
Post Stroke
Neural mechanisms
Motor Control
Motor Function

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 29, 2014