Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke

Stroke Clinical Trial

Official title:

Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04188769
• Other study ID #: EC/2019/1776
• Status: Withdrawn
• Phase: N/A
• Start date: December 2019
• Est. completion date: April 2020

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effect of - both constant as intermittent - local application of deep pressure on muscle activity and general relaxation in persons with hypertonia following stroke.

Description:

This study will be carried out in 20 persons with hypertonia following stroke. There will be one single test occasion, during which 6 test trials will be performed in random order. Deep pressure will be applied by means of a Johnstone air splint, that will be (1) not inflated, (2) inflated constantly, or (3) inflated intermittently. Each of these 3 inflation conditions will be performed twice, i.e. with and without a non-hemiplegic arm movement (triggering hypertonia at hemiplegic side).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• subacute stroke (<6 months)

• hypertonia (Modified Ashworth Scale score of =2 for arm flexors at the hemiplegic side)

Related Conditions & MeSH terms

• Deep Pressure
• General Relaxation
• Hypertonia, Muscle
• Muscle Activity
• Muscle Hypertonia
• Stroke

Intervention

Device:
• constant deep pressure applied by an air splint
inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm
• intermittent deep pressure applied by an air splint
continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm
• uninflated air splint
no deep pressure applied by the air splint

Other:
• contralateral movement
non-hemiplegic arm is flexed and extended 5 times, with a weight of 5kg in the hand, in order to trigger hypertonia in the hemiplegic arm

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMG of biceps brachii	electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side	through study completion, an average of 5 months
Primary	EMG of triceps brachii	electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side	through study completion, an average of 5 months
Primary	EMG of pectoralis major	electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side	through study completion, an average of 5 months
Primary	MyotonPRO measurement of pectoralis major muscle tone	MyotonPRO measurement of pectoralis major muscle tone	through study completion, an average of 5 months
Primary	heart rate	heart rate measurement assessed with the Zehpyr bioharness	through study completion, an average of 5 months
Primary	heart rate variability	heart rate variability assessed with the Zehpyr bioharness	through study completion, an average of 5 months
Primary	respiratory rate	respiratory rate assessed with the Zehpyr bioharness	through study completion, an average of 5 months
Primary	subjective rating of hypertonia	visual analogue scale rating of the intensity of hypertonia, in which the degree of hypertonia has to be situated between "0" (no hypertonia) and "10" (very severe hypertonia)	through study completion, an average of 5 months
Secondary	MyotonPRO measurement of pectoralis major elasticity	MyotonPRO measurement of pectoralis major elasticity	through study completion, an average of 5 months
Secondary	MyotonPRO measurement of pectoralis major stiffness	MyotonPRO measurement of pectoralis major stiffness	through study completion, an average of 5 months