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NCT Number: NCT05179473

Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. TSRT

    Time frame: up to 16 weeks

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

  2. Mu

    Time frame: up to 16 weeks

    Velocity sensitivity of the TSRT

  3. 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

  4. Reflexes

    Time frame: up to 16 weeks

    Measured in the elbow flexors or ankle plantarflexors

Secondary outcomes

  1. Active Range of Motion (AROM)

    Time frame: up to 16 weeks

    Measured in elbow or ankle for flexion and extension

  2. Passive Range of Motion (PROM)

    Time frame: up to 16 weeks

    Measured in elbow or ankle for flexion and extension

  3. Semmes-Weinstein filaments

    Time frame: up to 16 weeks

    Measure of the sensory threshold in index and thumb or first toe and middle-plantar surface of the foot

  4. Maximal Voluntary Force (MVF)

    Time frame: up to 16 weeks

    Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors

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

    Time frame: up to 16 weeks

    Assessment of motor function, balance, sensation and joint function in the upper and lower limb

  6. Berg Balance Scale

    Time frame: up to 16 weeks

    Measure of balance in standing

  7. Box and Blocks Test (BBT)

    Time frame: up to 16 weeks

    Number of blocks moved by the more-affected arm compared to the less-affected arm

  8. Timed Up and Go (TUG)

    Time frame: up to 16 weeks

    Activity measure of whole body function

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Misana, PT

CONTACT

[email protected]

450-688-9550 ext. 84655

Mindy F. Levin, PT, PhD

CONTACT

[email protected]

450-688-9550 ext. 84371

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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