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Therapies for Recovery of Hand Function After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574623
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Kessler Foundation
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Cleveland Clinic
Johns Hopkins University
Emory University
Information provided by (Responsible Party):
Jayme Knutson, MetroHealth Medical Center

Brief Summary:
After a stroke, it is very common to lose the ability to open the affected hand. The purpose of this study is to compare the effects of three different therapies on recovery of hand function after stroke and determine if any one is better than the other.

Condition or disease Intervention/treatment Phase
Stroke Upper Extremity Paresis Hemiplegia Device: Electrical Stimulator Behavioral: Occupational Therapy Not Applicable

Detailed Description:
A single-blinded randomized controlled trial will be carried out to assess and compare the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES), Cyclic Neuromuscular Electrical Stimulation (cNMES), and Task Oriented Training. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 weeks. The treatment dose will be the same for all three groups: 10 sessions per week of self-administered treatment at home plus 2 sessions per week of group-specific occupational therapy in the lab.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: CCFES
Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.
Device: Electrical Stimulator
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).

Behavioral: Occupational Therapy
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Active Comparator: cNMES
Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.
Device: Electrical Stimulator
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).

Behavioral: Occupational Therapy
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.

Active Comparator: Task Oriented Therapy
Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.
Behavioral: Occupational Therapy
Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.




Primary Outcome Measures :
  1. Box and Blocks Test (BBT) change [ Time Frame: 0 to 12 weeks, 0 to 36 weeks ]
    The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.


Secondary Outcome Measures :
  1. Stroke Upper Limb Capacity Scale (SULCS) change [ Time Frame: 0 to 12 weeks, 0 to 36 weeks ]
    The SULCS is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity.



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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
  • unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale
  • score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment
  • adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)
  • able to follow 3-stage commands
  • able to recall at least 2 of a list of 3 items after 30 minutes
  • skin intact on the hemiparetic arm
  • surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity)
  • able to hear and respond to cues from stimulator
  • not receiving occupational therapy (no concomitant OT)
  • full voluntary opening/closing of the contralateral (less affected) hand
  • demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them

Exclusion Criteria:

  • co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
  • uncontrolled seizure disorder
  • brainstem stroke
  • uncompensated hemineglect
  • severe shoulder or hand pain
  • insensate forearm or hand
  • history of potentially fatal cardiac arrhythmias with hemodynamic instability
  • implanted electronic systems (e.g. pacemaker)
  • botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
  • pregnant women due to unknown risks of surface NMES during pregnancy
  • lack of functional passive range of motion of the wrist or fingers of affected side
  • diagnosis (apart from stroke) that substantially affects paretic arm and hand function
  • deficits in communication that interfere with reasonable study participation
  • lacking sufficient visual acuity to see the stimulator's display
  • concurrent enrollment in another investigational study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574623


Contacts
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Contact: Amy Friedl, OT 216-778-5347 afreidl@metrohealth.org

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Christine Towler    404-321-6111 ext 202561    christine.towler@va.gov   
Principal Investigator: AM Barrett, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Maria Pena Prieto    410-955-1347    mpenapr1@jhmi.edu   
Principal Investigator: Preeti Raghavan, MD         
United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny Masmela    973-324-3564    jmasmela@kesslerfoundation.org   
Contact: Amanda PraSisto    973-324-3519      
Principal Investigator: Olga Boukrina, PhD         
United States, Ohio
MetroHealth Rehabilitation Institute Recruiting
Cleveland, Ohio, United States, 44109
Contact: Amy Friedl, OTR/L    216-957-3581    afriedl@metrohealth.org   
Principal Investigator: Jayme Knutson, PhD         
Sponsors and Collaborators
MetroHealth Medical Center
Kessler Foundation
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Cleveland Clinic
Johns Hopkins University
Emory University
Investigators
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Principal Investigator: Jayme Knutson, PhD MetroHealth Medical Center

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Responsible Party: Jayme Knutson, Senior Staff Scientist, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03574623    
Other Study ID Numbers: IRB17-00884
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jayme Knutson, MetroHealth Medical Center:
stroke
rehabilitation
therapy
electrical stimulation
hand
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms