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Clinical Trials/NCT05179473
NCT05179473
Recruiting
N/A

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

McGill University1 site in 1 country12 target enrollmentJune 17, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
McGill University
Enrollment
12
Locations
1
Primary Endpoint
TSRT
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 17, 2021
End Date
December 30, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mindy F. Levin

Professor

McGill University

Eligibility Criteria

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

Outcomes

Primary Outcomes

TSRT

Time Frame: up to 16 weeks

Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors

Mu

Time Frame: up to 16 weeks

Velocity sensitivity of the TSRT

Modified Ashworth Scale (MAS)

Time Frame: up to 16 weeks

Measure of the increase of muscle resistance to stretch felt by examiner in the elbow flexors or ankle plantarflexors

Reflexes

Time Frame: up to 16 weeks

Measured in the elbow flexors or ankle plantarflexors

Secondary Outcomes

  • Berg Balance Scale(up to 16 weeks)
  • Box and Blocks Test (BBT)(up to 16 weeks)
  • Passive Range of Motion (PROM)(up to 16 weeks)
  • Semmes-Weinstein filaments(up to 16 weeks)
  • Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)(up to 16 weeks)
  • Timed Up and Go (TUG)(up to 16 weeks)
  • Active Range of Motion (AROM)(up to 16 weeks)
  • Maximal Voluntary Force (MVF)(up to 16 weeks)

Study Sites (1)

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