Validation of a Spasticity Measurement Tool

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Recruiting
CT.gov ID
NCT05374174
Collaborator
(none)
25
1
26.1
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Validation of a Spasticity Measurement Tool
Actual Study Start Date :
Apr 28, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Catch angle [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 Outcome Measures

  1. Modified ashworth score [Baseline]

    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

  2. Tardieu Spasticity Score [Baseline]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: William Z Rymer, MD, PhD, Director, Single Motor Unit Laboratory

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zev Rymer, Director Single Motor Unit Laboratory, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT05374174
Other Study ID Numbers:
  • STU00216437
First Posted:
May 16, 2022
Last Update Posted:
May 16, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zev Rymer, Director Single Motor Unit Laboratory, Shirley Ryan AbilityLab
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2022