Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179473
• Other study ID #: MP-37-2019-5298
• Status: Recruiting
• Start date: June 17, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: McGill University
• Contact: Mindy F. Levin, PT, PhD
• Phone: 450-688-9550
• Email: mindy.levin[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Acute
• Stroke, Ischemic

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TSRT	Tonic stretch reflex threshold measured in the elbow flexors or ankle plantarflexors	up to 16 weeks
Primary	Mu	Velocity sensitivity of the TSRT	up to 16 weeks
Primary	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
Primary	Reflexes	Measured in the elbow flexors or ankle plantarflexors	up to 16 weeks
Secondary	Active Range of Motion (AROM)	Measured in elbow or ankle for flexion and extension	up to 16 weeks
Secondary	Passive Range of Motion (PROM)	Measured in elbow or ankle for flexion and extension	up to 16 weeks
Secondary	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
Secondary	Maximal Voluntary Force (MVF)	Measured in the elbow flexors and extensors, and in the ankle dorsiflexors and plantarflexors	up to 16 weeks
Secondary	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
Secondary	Berg Balance Scale	Measure of balance in standing	up to 16 weeks
Secondary	Box and Blocks Test (BBT)	Number of blocks moved by the more-affected arm compared to the less-affected arm	up to 16 weeks
Secondary	Timed Up and Go (TUG)	Activity measure of whole body function	up to 16 weeks