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MyoSense- Automated Muscle Hypertonicity Classification System

MyoSense- Automated Muscle Hypertonicity Classification System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02076581
Enrollment
53
Registered
2014-03-03
Start date
2014-02-28
Completion date
2015-04-30
Last updated
2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Dystonia, Stroke

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.

Interventions

None listed

Sponsors

The Cleveland Clinic
CollaboratorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Great Lakes NeuroTechnologies Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between clinician and device measured abnormal tone type.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026