Try our beta test site

MyoSense- Automated Muscle Hypertonicity Classification System

This study has been completed.
The Cleveland Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc. Identifier:
First received: February 20, 2014
Last updated: May 28, 2015
Last verified: May 2015
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.

Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: MyoSense- Automated Muscle Hypertonicity Classification System

Resource links provided by NLM:

Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Primary Outcome Measures:
  • 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.

Enrollment: 53
Study Start Date: February 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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.


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.
  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 identifier: 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.
  More Information

Responsible Party: Great Lakes NeuroTechnologies Inc. Identifier: NCT02076581     History of Changes
Other Study ID Numbers: NS076052-1
1R43NS076052-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: February 20, 2014
Last Updated: May 28, 2015

Additional relevant MeSH terms:
Muscle Hypertonia
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Neuromuscular Manifestations processed this record on March 30, 2017