Validation of a Spasticity Measurement Tool

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Tardieu Scale for Spasticity

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons who have experienced a unilateral stroke

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Measurement Group; All participants will have their arm spasticity to be measured using standard clinical scales	Diagnostic test: Tardieu Scale for Spasticity; The clinician will rotate the elbow joint at various speeds while the participant sits relaxed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catch angle	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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified ashworth score	Clinical measure of tone in the elbow. Participant is relaxed while the clinician rotates the elbow through the range of motion. Scale is rated from 0-4 where 0 is tone, 1 is slight increase in tone, catch at end of range of motion, 1+ is slight increase in tone, catch in 1st half of range of motion, 2 is increased tone throughout range of motion, but still moveable, 3 is a considerable increase in tone, and 4 is a rigid limb. This measure will be taken at 2 minute increments over 30 minutes	Baseline
Tardieu Spasticity Score	Clinical measure of catch angle during fast elbow rotation. Participant is relaxed while the clinician rotates the elbow through the range of motion quickly and slowly. Angle of catch is recorded for this scale, measured with goniometer. The quantitative score is from 0-4, It is scored as 0, no resistance, 1 slight resistance, 2 clear catch followed by release, 3 clonus which dissipates in less than 10 seconds, and 4 is clonus lasting more than 10 seconds. This measure will be taken at 2 minute increments over 30 minutes	Baseline

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: William Z Rymer, MD, PhD, Director, Single Motor Unit Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Spasticity; Hyperreflexia; Clonus; Hypertonia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Stroke; Muscle Hypertonia; Reflex, Abnormal
• Other Study ID Numbers: STU00216437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No