Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorMcGill University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Acute stroke in Middle Cerebral Artery area resulting in hemiparesis.

Hemorrhagic or ischemic

Medically stable

Able to provide informed consent

Disqualifiers

Severe cognitive disorders

Ataxia

Trial population

Patients will be recruited from acute care facilities such as general hospitals and stroke units in Montreal area hospitals.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

12 Participants
are grouped into 1 trial group
Group A: Acute stroke patients

Trial outcomes

Primary outcomes

1

TSRT

Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors

Time frame
up to 16 weeks
2

Mu

Velocity sensitivity of the TSRT

Time frame
up to 16 weeks
3

Modified Ashworth Scale (MAS)

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
4

Reflexes

Measured in the elbow flexors or ankle plantarflexors

Time frame
up to 16 weeks

Secondary outcomes

1

Active Range of Motion (AROM)

Measured in elbow or ankle for flexion and extension

Time frame
up to 16 weeks
2

Passive Range of Motion (PROM)

Measured in elbow or ankle for flexion and extension

Time frame
up to 16 weeks
3

Semmes-Weinstein filaments

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
4

Maximal Voluntary Force (MVF)

Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors

Time frame
up to 16 weeks

Other outcomes

Sponsors and contacts

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