Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients
- Conditions
- Stroke, IschemicStroke, AcuteSpasticity as Sequela of StrokeStroke Hemorrhagic
- Registration Number
- NCT05179473
- Lead Sponsor
- McGill University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- Acute stroke in Middle Cerebral Artery area resulting in hemiparesis.
- Hemorrhagic or ischemic
- Medically stable
- Able to provide informed consent
- Severe cognitive disorders
- Ataxia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TSRT up to 16 weeks Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors
Mu up to 16 weeks Velocity sensitivity of the TSRT
Modified Ashworth Scale (MAS) up to 16 weeks Measure of the increase of muscle resistance to stretch felt by examiner in the elbow flexors or ankle plantarflexors
Reflexes up to 16 weeks Measured in the elbow flexors or ankle plantarflexors
- Secondary Outcome Measures
Name Time Method Berg Balance Scale up to 16 weeks Measure of balance in standing
Box and Blocks Test (BBT) up to 16 weeks Number of blocks moved by the more-affected arm compared to the less-affected arm
Passive Range of Motion (PROM) up to 16 weeks Measured in elbow or ankle for flexion and extension
Semmes-Weinstein filaments up to 16 weeks Measure of the sensory threshold in index and thumb or first toe and middle-plantar surface of the foot
Fugl-Meyer Assessment Upper Limb/Lower Limb (FMA - UL/LL) up to 16 weeks Assessment of motor function, balance, sensation and joint function in the upper and lower limb
Timed Up and Go (TUG) up to 16 weeks Activity measure of whole body function
Active Range of Motion (AROM) up to 16 weeks Measured in elbow or ankle for flexion and extension
Maximal Voluntary Force (MVF) up to 16 weeks Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors
Trial Locations
- Locations (1)
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada