StrokeNCT05374174
Validation of a Spasticity Measurement Tool
An observational study of Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Tardieu Scale for Spasticity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons who have experienced a unilateral stroke
Who may be able to join
- Age 18-75
- Able to provide informed consent
- History of unilateral stroke
Who cannot join
- Orthopedic injuries or surgeries that would impact arm function
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Tardieu Scale for Spasticity
- Keywords
- Spasticity, Hyperreflexia, Clonus, Hypertonia
- Medical subject headings
- Stroke, Muscle Spasticity, Reflex, Abnormal, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tardieu Scale for SpasticityDiagnostic test
The clinician will rotate the elbow joint at various speeds while the participant sits relaxed.
| Study group | Role | What they receive |
|---|---|---|
| Measurement Group | All participants will have their arm spasticity to be measured using standard clinical scales Receives: Diagnostic Test: Tardieu Scale for Spasticity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start28 Apr 2022
- Primary completion1 Feb 2026
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zev Rymer, Shirley Ryan AbilityLab
- Investigators
- William Z Rymer, MD, PhD, Principal investigator, Director, Single Motor Unit Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374174
- Sponsor's protocol ID
- STU00216437
- Status last verified
- Mar 2026
- First submitted
- 5 May 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Spasticity Measurement Tool
- ClinicalTrials.gov ID
- NCT05374174
- Acronym / sponsor ID
- STU00216437
- Conditions
- Stroke
- Keywords
- Spasticity, Hyperreflexia, Clonus, Hypertonia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measurement Group | – | Diagnostic Test: Tardieu Scale for SpasticityAll participants will have their arm spasticity to be measured using standard clinical scales |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons who have experienced a unilateral stroke
Key inclusion criteria (3 listed)
- Age 18-75
- Able to provide informed consent
- History of unilateral stroke
Key exclusion criteria (1 listed)
- Orthopedic injuries or surgeries that would impact arm function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tardieu Scale for SpasticityThe clinician will rotate the elbow joint at various speeds while the participant sits relaxed. | Diagnostic test | Measurement Group |
Primary outcome
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
2 secondary outcomes
Modified ashworth score
Time frame: Baseline
Tardieu Spasticity Score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Z Rymer, MD, PhD principal investigator
Director, Single Motor Unit Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catch angle (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.