Validation of a Spasticity Measurement Tool

NCT ID: NCT05374174

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2026-07-01

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Measurement Group

All participants will have their arm spasticity to be measured using standard clinical scales

Tardieu Scale for Spasticity

Intervention Type: DIAGNOSTIC_TEST

The clinician will rotate the elbow joint at various speeds while the participant sits relaxed.

Interventions

Tardieu Scale for Spasticity

The clinician will rotate the elbow joint at various speeds while the participant sits relaxed.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Zev Rymer

Director Single Motor Unit Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Z Rymer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Single Motor Unit Laboratory

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00216437

Identifier Type: -

Identifier Source: org_study_id