MyoSense- Automated Muscle Hypertonicity Classification System

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.

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Key information

Conditions

Stroke Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Dyskinesias Dystonia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Lakes NeuroTechnologies

Valley View, Ohio, 44125, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
The Cleveland Clinic

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 3, 2014
Registry last updated: Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed