MyoSense- Automated Muscle Hypertonicity Classification System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Correlation between clinician and device measured abnormal tone type.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported