Recruiting

Observational Study

Sponsor:

McGill University

Code:

NCT05179473

Conditions

Stroke, Acute

Stroke, Ischemic

Stroke Hemorrhagic

Spasticity as Sequela of Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05179473

Start date

Jun 17, 2021

Status verified date

May, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute stroke patients

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

Primary outcome measure

  • TSRT [ Time Frame: up to 16 weeks ]
  • Mu [ Time Frame: up to 16 weeks ]
  • Modified Ashworth Scale (MAS) [ Time Frame: up to 16 weeks ]
  • Reflexes [ Time Frame: up to 16 weeks ]

Central Contacts and Locations

Central contacts

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

More Information

Sponsor

McGill University

Last update posted

Jun 4, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2025-06-04.