NCT02076581|Completed
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Sponsor study identifier
Secondary identifiers
observational
53
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2014
Actual (reported)March 3, 2014
Actual (reported)April 2015
Actual (reported)April 2015
Actual (reported)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.
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.
Sixty individuals, including individuals with and without abnormal muscle tone will be recruited for this study.
Great Lakes NeuroTechnologies
Valley View, Ohio, 44125, United States
Joseph P Giuffrida, PhD
Great Lakes NeuroTechnologies Inc.
53 participants (actual enrollment reported by the registry).
First Submitted
February 20, 2014
First Posted
March 3, 2014
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Arm Motor Control on Bi and Uni ADLs
Contact the study team to confirm eligibility.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
June 1, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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