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Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05179473
Enrollment
12
Registered
2022-01-05
Start date
2021-06-17
Completion date
2025-12-30
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

McGill University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TSRTup to 16 weeksTonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors
Muup to 16 weeksVelocity sensitivity of the TSRT
Modified Ashworth Scale (MAS)up to 16 weeksMeasure of the increase of muscle resistance to stretch felt by examiner in the elbow flexors or ankle plantarflexors
Reflexesup to 16 weeksMeasured in the elbow flexors or ankle plantarflexors

Secondary

MeasureTime frameDescription
Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)up to 16 weeksAssessment of motor function, balance, sensation and joint function in the upper and lower limb
Berg Balance Scaleup to 16 weeksMeasure of balance in standing
Active Range of Motion (AROM)up to 16 weeksMeasured in elbow or ankle for flexion and extension
Timed Up and Go (TUG)up to 16 weeksActivity measure of whole body function
Box and Blocks Test (BBT)up to 16 weeksNumber of blocks moved by the more-affected arm compared to the less-affected arm
Passive Range of Motion (PROM)up to 16 weeksMeasured in elbow or ankle for flexion and extension
Semmes-Weinstein filamentsup to 16 weeksMeasure of the sensory threshold in index and thumb or first toe and middle-plantar surface of the foot
Maximal Voluntary Force (MVF)up to 16 weeksMeasured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors

Countries

Canada

Contacts

Primary ContactMindy F. Levin, PT, PhD
mindy.levin@mcgill.ca450-688-9550
Backup ContactAlice Misana, PT
alice.misana@mail.mcgill.ca450-688-9550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026