MyoSense- Automated Muscle Hypertonicity Classification System
|ClinicalTrials.gov Identifier: NCT02076581|
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : June 1, 2015
|Condition or disease|
|Stroke Dystonia Cerebral Palsy|
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||MyoSense- Automated Muscle Hypertonicity Classification System|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Ten individuals with chronic stroke and limb spasticity will be recruited.
Ten individuals with dystonic limbs and no spasticity will be recruited.
Ten individuals with Cerebral palsy with the potential for a mix of dystonic and spastic abnormal tone in their affected limbs will be recruited.
Thirty individuals without neurological injury that are age matched to the rest of the study population will be recruited.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076581
|United States, Ohio|
|Great Lakes NeuroTechnologies|
|Valley View, Ohio, United States, 44125|
|Principal Investigator:||Joseph P Giuffrida, PhD||Great Lakes NeuroTechnologies Inc.|