MyoSense- Automated Muscle Hypertonicity Classification System

Stroke Clinical Trial

Official title:

MyoSense- Automated Muscle Hypertonicity Classification System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076581
• Other study ID #: NS076052-1
• Secondary ID: 1R43NS076052-01A
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: May 28, 2015
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Great Lakes NeuroTechnologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebral Palsy
• Dystonia
• Muscle Hypertonia
• Stroke

Locations

Country	Name	City	State
United States	Great Lakes NeuroTechnologies	Valley View	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Great Lakes NeuroTechnologies Inc.	National Institute of Neurological Disorders and Stroke (NINDS), The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between clinician and device measured abnormal tone type.	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.	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.	No