Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

NCT05179473 | Recruiting DMC

• 1 other identifier: MP-37-2019-5298
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute; Stroke, Ischemic; Stroke Hemorrhagic; Spasticity as Sequela of Stroke

Keywords

stroke; spasticity; imaging; prognosis; diagnosis; upper limb; lower limb

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Active Range of Motion (AROM)

  up to 16 weeks

• Passive Range of Motion (PROM)

  up to 16 weeks

• Semmes-Weinstein filaments

  up to 16 weeks

• Maximal Voluntary Force (MVF)

  up to 16 weeks

• Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)

  up to 16 weeks

Study Arms (1)

Acute stroke patients

12 weekly evaluations starting within the first week post-stroke. Follow-up assessment at week 16. MRI at week 6.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Severe cognitive disorders
• Ataxia

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Muscle Spasticity; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Theodore Wein, MD

  Montreal Neurological Institute

  PRINCIPAL INVESTIGATOR

• Alexander Thiel, MD

  Jewish General Hospital - McGill University

  STUDY CHAIR

• Marie-Helene Boudrias, PT, PhD

  McGill University

  STUDY CHAIR

Central Study Contacts

Mindy F. Levin, PT, PhD

CONTACT

450-688-9550; mindy.levin@mcgill.ca

Alice Misana, PT

CONTACT

450-688-9550; alice.misana@mail.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 5, 2022
• Study Start: June 17, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)