Stroke, AcuteNCT05179473
Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients
An observational study of Stroke, Acute and Stroke, Ischemic, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from acute care facilities such as general hospitals and stroke units in Montreal area hospitals.
Who may be able to join
- Acute stroke in Middle Cerebral Artery area resulting in hemiparesis.
- Hemorrhagic or ischemic
- Medically stable
- Able to provide informed consent
Who cannot join
- Severe cognitive disorders
- Ataxia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Sharon Shapiro, 514-340-8222 ext. 22094, sshapiro@jgh.mcgill.ca
About this study
Official title: 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.
Read more
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.
- Keywords
- stroke, spasticity, imaging, prognosis, diagnosis, upper limb, lower limb
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Muscle Spasticity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
TSRT
Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors
Measured: up to 16 weeks
Mu
Velocity sensitivity of the TSRT
Measured: 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
Measured: up to 16 weeks
Reflexes
Measured in the elbow flexors or ankle plantarflexors
Measured: up to 16 weeks
Secondary outcomes (8)
Active Range of Motion (AROM)
Measured in elbow or ankle for flexion and extension
Measured: up to 16 weeks
Passive Range of Motion (PROM)
Measured in elbow or ankle for flexion and extension
Measured: 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
Measured: up to 16 weeks
Maximal Voluntary Force (MVF)
Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors
Measured: 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
Measured: up to 16 weeks
Berg Balance Scale
Measure of balance in standing
Measured: up to 16 weeks
Box and Blocks Test (BBT)
Number of blocks moved by the more-affected arm compared to the less-affected arm
Measured: up to 16 weeks
Timed Up and Go (TUG)
Activity measure of whole body function
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start17 Jun 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mindy F. Levin, McGill University
- Investigators
- Theodore Wein, MD, Principal investigator, Montreal Neurological InstituteAlexander Thiel, MD, Study chair, Jewish General Hospital - McGill UniversityMarie-Helene Boudrias, PT, PhD, Study chair, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179473
- Sponsor's protocol ID
- MP-37-2019-5298
- Status last verified
- May 2025
- First submitted
- 10 Dec 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Practice: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT05179473
- Acronym / sponsor ID
- MP-37-2019-5298
- Keywords
- stroke, spasticity, imaging, prognosis, diagnosis, upper limb, lower limb
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | – | –12 weekly evaluations starting within the first week post-stroke. Follow-up assessment at week 16. MRI at week 6. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from acute care facilities such as general hospitals and stroke units in Montreal area hospitals.
Key inclusion criteria (4 listed)
- Acute stroke in Middle Cerebral Artery area resulting in hemiparesis.
- Hemorrhagic or ischemic
- Medically stable
- Able to provide informed consent
Key exclusion criteria (2 listed)
- Severe cognitive disorders
- Ataxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Active Range of Motion (AROM)
Time frame: up to 16 weeks
Passive Range of Motion (PROM)
Time frame: up to 16 weeks
Semmes-Weinstein filaments
Time frame: up to 16 weeks
Maximal Voluntary Force (MVF)
Time frame: up to 16 weeks
Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)
Time frame: up to 16 weeks
Berg Balance Scale
Time frame: up to 16 weeks
Box and Blocks Test (BBT)
Time frame: up to 16 weeks
Timed Up and Go (TUG)
Time frame: up to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theodore Wein, MD principal investigator
Montreal Neurological Institute
Alexander Thiel, MD study chair
Jewish General Hospital - McGill University
Marie-Helene Boudrias, PT, PhD study chair
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Stroke, Ischemic, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mindy F. Levin, PT, PhD (450-688-9550 ext. 84371, mindy.levin@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSRT (time frame: up to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.