Clinical trial NCT05179473: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients
Official title: Changing Practice: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Stroke, Ischemic
Stroke Hemorrhagic
Spasticity as Sequela of Stroke
Keywords: stroke
spasticity
imaging
prognosis
diagnosis
upper limb
lower limb
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from acute care facilities such as general hospitals and stroke units in Montreal area hospitals.

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.


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
* Ataxia

Primary outcomes:
measure: TSRT
timeFrame: up to 16 weeks
measure: Mu
timeFrame: up to 16 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: up to 16 weeks
measure: Reflexes
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Active Range of Motion (AROM)
timeFrame: up to 16 weeks
measure: Passive Range of Motion (PROM)
timeFrame: up to 16 weeks
measure: Semmes-Weinstein filaments
timeFrame: up to 16 weeks
measure: Maximal Voluntary Force (MVF)
timeFrame: up to 16 weeks
measure: Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL)
timeFrame: up to 16 weeks
measure: Berg Balance Scale
timeFrame: up to 16 weeks
measure: Box and Blocks Test (BBT)
timeFrame: up to 16 weeks
measure: Timed Up and Go (TUG)
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Montreal Neurological Institute
name: Theodore Wein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish General Hospital - McGill University
name: Alexander Thiel, MD
role: STUDY_CHAIR
affiliation: McGill University
name: Marie-Helene Boudrias, PT, PhD
role: STUDY_CHAIR
References: