Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

Sponsor

McGill University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05179473

Collaborator

(none)

Enrollment

Location

17.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute Stroke, Ischemic Stroke Hemorrhagic Spasticity as Sequela of Stroke

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 17, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Active Range of Motion (AROM) [up to 16 weeks]
Measured in elbow or ankle for flexion and extension
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
Maximal Voluntary Force (MVF) [up to 16 weeks]
Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors
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
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
Timed Up and Go (TUG) [up to 16 weeks]
Activity measure of whole body function