Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Location status: Recruiting
NCT Number: NCT05179473
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Montreal, Quebec, H3T 1E2, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 16 weeks
Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors
Time frame: up to 16 weeks
Velocity sensitivity of the TSRT
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
Time frame: up to 16 weeks
Measured in the elbow flexors or ankle plantarflexors
Time frame: up to 16 weeks
Measured in elbow or ankle for flexion and extension
Time frame: up to 16 weeks
Measured in elbow or ankle for flexion and extension
Time frame: up to 16 weeks
Measure of the sensory threshold in index and thumb or first toe and middle-plantar surface of the foot
Time frame: up to 16 weeks
Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors
Time frame: up to 16 weeks
Assessment of motor function, balance, sensation and joint function in the upper and lower limb
Time frame: up to 16 weeks
Measure of balance in standing
Time frame: up to 16 weeks
Number of blocks moved by the more-affected arm compared to the less-affected arm
Time frame: up to 16 weeks
Activity measure of whole body function
Contact information is provided by the study sponsor or research team.
Alice Misana, PT
CONTACT
450-688-9550 ext. 84655
Mindy F. Levin, PT, PhD
CONTACT
450-688-9550 ext. 84371
McGill University
Other
Changing Practice: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients: a Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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