Trial record 13 of 353 for:    Hypertonia

MyoSense- Automated Muscle Hypertonicity Classification System

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. Read our disclaimer for details. Identifier: NCT02076581
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : June 1, 2015
The Cleveland Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.

Brief Summary:
It is often difficult to quantify and distinguish aspects of abnormal muscle tone due to neurological injury. This makes it difficult to evaluate therapies that aim to reduce the effects of abnormal muscle tone. This research study will evaluate the feasibility of a clinician worn device to capture and quantify features of spasticity and dystonia.

Condition or disease
Stroke Dystonia Cerebral Palsy

Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: MyoSense- Automated Muscle Hypertonicity Classification System
Study Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Ten individuals with chronic stroke and limb spasticity will be recruited.
Ten individuals with dystonic limbs and no spasticity will be recruited.
Cerebral Palsy
Ten individuals with Cerebral palsy with the potential for a mix of dystonic and spastic abnormal tone in their affected limbs will be recruited.
Neurologically normal
Thirty individuals without neurological injury that are age matched to the rest of the study population will be recruited.

Primary Outcome Measures :
  1. Correlation between clinician and device measured abnormal tone type. [ Time Frame: For each subject clinician and device data will be collected within a single session. Each session will occur over a maximum of two hours. Analysis of all of the subject data will be completed within 30 days of study completion. ]
    Device measurements of clinician applied force relative to limb manipulation speed will be compared to conventional clinical outcome measures. For example, correlation between the slope of the force to speed profile and clinician evaluated spasticity, Ashworth score, will be calculated.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.

Inclusion Criteria:

  • Presentation of dystonia and/or spasticity or, if in control group, no neurological injury nor abnormal muscle tone
  • Over the age of five.

Exclusion Criteria:

  • Intolerable pain with manipulation of the knee, ankle, wrist, or elbow
  • Limited range of motion in the knee, ankle, wrist or elbow due to orthopedic injury or severe contraction.
  • Cognitive impairment resulting in inability to provide informed consent or complete the protocol.
  • Under the age of five.

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 identifier (NCT number): NCT02076581

United States, Ohio
Great Lakes NeuroTechnologies
Valley View, Ohio, United States, 44125
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
The Cleveland Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Joseph P Giuffrida, PhD Great Lakes NeuroTechnologies Inc.

Responsible Party: Great Lakes NeuroTechnologies Inc. Identifier: NCT02076581     History of Changes
Other Study ID Numbers: NS076052-1
1R43NS076052-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Muscle Hypertonia
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neuromuscular Manifestations