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Clinical Trials/NCT05374174
NCT05374174
Active, Not Recruiting
N/A

Validation of a Spasticity Measurement Tool

Shirley Ryan AbilityLab1 site in 1 country40 target enrollmentApril 28, 2022
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Shirley Ryan AbilityLab
Enrollment
40
Locations
1
Primary Endpoint
Catch angle
Status
Active, Not Recruiting
Last Updated
last month

Overview

Brief Summary

The objective of this project is to investigate the validity of a handheld spasticity measurement tool against standard clinical measurements of spasticity. We propose the testing apparatus will accurately provide an equivalent clinical measure of spasticity while also providing a more precise estimation of spastic response in persons with stroke.

Detailed Description

An ongoing conversation amongst clinicians exists on how to properly define, measure, and manage spasticity. The standard measurement tools are the Modified Ashworth Scale (MAS) and the Tardieu scale, although both of these lack reliability and specificity, causing variability between clinicians and a lack of accurate spasticity measurement. In addition, some have concerns about whether the MAS measures true spasticity at all. Due to this lack of trust in these scales, clinicians often use them as a communication tool to identify the presence of spasticity, rather than as reliable quantifiable outcome measurements. The MAS and Tardieu function mainly on the principal of catch, a limb is moved slowly by a clinician through the available range of motion, and then quickly. Hyperactive muscles are sensitive to velocity dependent stretch and will activate a reflex if quickly perturbed. In both the MAS and Tardieu, the catch location is noted and translated into a score. In MAS the catch location is only noted in three distinct ranges; with the Tardieu Scale the catch angle is remembered by the clinician and recorded after the movement with a standard goniometer. Here we will test a new handheld spasticity measurement tool MITSS (Modified Intelligent Tardieu Scale for Spasticity), which is essentially a 3-DOF digital goniometer, to quantify the catch angle as well as general forces at the joint.

Registry
clinicaltrials.gov
Start Date
April 28, 2022
End Date
February 1, 2027
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zev Rymer

Director Single Motor Unit Laboratory

Shirley Ryan AbilityLab

Eligibility Criteria

Inclusion Criteria

  • Age 18-75
  • Able to provide informed consent
  • History of unilateral stroke

Exclusion Criteria

  • Orthopedic injuries or surgeries that would impact arm function

Outcomes

Primary Outcomes

Catch angle

Time Frame: Baseline

Elbow angle in which there is a marked increase in tone while rotating quickly. This is measured while the clinician is wearing the MITSS and rotating participant's elbow slowly and quickly through the range of motion. This measure will be taken at 2 minute increments over 30 minutes

Secondary Outcomes

  • Modified ashworth score(Baseline)
  • Tardieu Spasticity Score(Baseline)

Study Sites (1)

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