Validation of a Spasticity Measurement Tool

NCT05374174 | Active Not Recruiting

• 1 other identifier: STU00216437
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Spasticity; Hyperreflexia; Clonus; Hypertonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Modified ashworth score

  Baseline

• Tardieu Spasticity Score

  Baseline

Study Arms (1)

Measurement Group

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

Diagnostic Test: Tardieu Scale for Spasticity

Interventions

Tardieu Scale for Spasticity DIAGNOSTIC_TEST

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

Measurement Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons who have experienced a unilateral stroke

You may qualify if:

• Age 18-75
• Able to provide informed consent
• History of unilateral stroke

You may not qualify if:

• Orthopedic injuries or surgeries that would impact arm function

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Reflex, Abnormal; Muscle Hypertonia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Z Rymer, MD, PhD

  Director, Single Motor Unit Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Single Motor Unit Laboratory

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 16, 2022
• Study Start: April 28, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)