ClinicalTrials.Veeva

Menu

Validation of a Spasticity Measurement Tool

Shirley Ryan AbilityLab logo

Shirley Ryan AbilityLab

Status

Active, not recruiting

Conditions

Stroke

Treatments

Diagnostic Test: Tardieu Scale for Spasticity

Study type

Observational

Funder types

Other

Identifiers

NCT05374174
STU00216437

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Measurement Group
Description:
All participants will have their arm spasticity to be measured using standard clinical scales
Treatment:
Diagnostic Test: Tardieu Scale for Spasticity

Trial contacts and locations

1

Loading...

Central trial contact

Alexander Barry, MS, CCRC

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems