Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

Changing Practice: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients: a Pilot Study

Spasticity, or greater muscle resistance, is a major disabling condition following stroke. Recovery of lost motor function in patients with stroke may be affected by spasticity, which most commonly develops in elbow and ankle muscles. However, despite its clinical relevance, the natural development of spasticity over the first 3 months after stroke is not clearly understood. Indeed, common clinical measures of spasticity such as the Modified Ashworth Scale (MAS) do not take into account the neurophysiological origin of spasticity and lack reliability and objectivity.

The objective of this study is to examine the natural history of the development of spasticity among patients with stroke over the first 3 months using a new neurophysiological measure (TSRT, the tonic stretch reflex threshold angle) and its velocity sensitivity (mu) in comparison to MAS and other common clinical tests. In addition, detailed brain imaging will be used to understand the relationship between damage to brain regions relevant to the development of spasticity and TSRT/mu values.

It is hypothesized that 1) TSRT/mu will indicate the presence of spasticity earlier than MAS/clinical tests; 2) TSRT/mu measures will be more closely related to motor impairments and activity limitations than MAS; 3) the lesion severity (identified by imaging) will be related to the change in TSRT/mu values.

Outcomes will be measured in a pilot cohort of 12 patients hospitalized for first-ever stroke. Measurements will be taken at the bedside within the 1st week of the patient's admission and will be done once per week for 12 weeks with a follow-up at week 16. Brain Imaging will be done around the 6th week post-stroke.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic; Stroke, Acute; Stroke Hemorrhagic; Spasticity as Sequela of Stroke

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Mindy F. Levin, PT, PhD; Phone Number: 84371 450-688-9550; Email: mindy.levin@mcgill.ca
• Study Contact Backup: Name: Alice Misana, PT; Phone Number: 84655 450-688-9550; Email: alice.misana@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Sharon Shapiro; Phone Number: 22094 514-340-8222; Email: sshapiro@jgh.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from acute care facilities such as general hospitals and stroke units in Montreal area hospitals.

Description

Inclusion Criteria:

• Acute stroke in Middle Cerebral Artery area resulting in hemiparesis.
• Hemorrhagic or ischemic
• Medically stable
• Able to provide informed consent

Exclusion Criteria:

• Severe cognitive disorders
• Ataxia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute stroke patients; 12 weekly evaluations starting within the first week post-stroke. Follow-up assessment at week 16. MRI at week 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TSRT	Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors	up to 16 weeks
Mu	Velocity sensitivity of the TSRT	up to 16 weeks
Modified Ashworth Scale (MAS)	Measure of the increase of muscle resistance to stretch felt by examiner in the elbow flexors or ankle plantarflexors	up to 16 weeks
Reflexes	Measured in the elbow flexors or ankle plantarflexors	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Range of Motion (AROM)	Measured in elbow or ankle for flexion and extension	up to 16 weeks
Passive Range of Motion (PROM)	Measured in elbow or ankle for flexion and extension	up to 16 weeks
Semmes-Weinstein filaments	Measure of the sensory threshold in index and thumb or first toe and middle-plantar surface of the foot	up to 16 weeks
Maximal Voluntary Force (MVF)	Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors	up to 16 weeks
Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)	Assessment of motor function, balance, sensation and joint function in the upper and lower limb	up to 16 weeks
Berg Balance Scale	Measure of balance in standing	up to 16 weeks
Box and Blocks Test (BBT)	Number of blocks moved by the more-affected arm compared to the less-affected arm	up to 16 weeks
Timed Up and Go (TUG)	Activity measure of whole body function	up to 16 weeks

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Theodore Wein, MD, Montreal Neurological Institute; Study Chair: Alexander Thiel, MD, Jewish General Hospital - McGill University; Study Chair: Marie-Helene Boudrias, PT, PhD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: imaging; stroke; prognosis; lower limb; upper limb; spasticity; diagnosis
• 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; Muscle Hypertonia; Neuromuscular Manifestations; Ischemic Stroke; Hemorrhagic Stroke; Muscle Spasticity; Stroke
• Other Study ID Numbers: MP-37-2019-5298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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