Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

Study Overview
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Brief Summary
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute stroke patients<br>12 weekly evaluations starting within the first week post-stroke. Follow-up assessment at week 16. MRI at week 6. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSRT | Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors | up to 16 weeks | 
| Mu | Velocity sensitivity of the TSRT | 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 | up to 16 weeks | 
| Reflexes | Measured in the elbow flexors or ankle plantarflexors | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Range of Motion (AROM) | Measured in elbow or ankle for flexion and extension | up to 16 weeks | 
| Passive Range of Motion (PROM) | Measured in elbow or ankle for flexion and extension | 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 | up to 16 weeks | 
| Maximal Voluntary Force (MVF) | Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors | 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 | up to 16 weeks | 
| Berg Balance Scale | Measure of balance in standing | up to 16 weeks | 
| Box and Blocks Test (BBT) | Number of blocks moved by the more-affected arm compared to the less-affected arm | up to 16 weeks | 
| Timed Up and Go (TUG) | Activity measure of whole body function | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, spasticity, imaging, prognosis, diagnosis, upper limb, lower limb