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

Not Applicable

Withdrawn

• Conditions: Stroke; Deep Pressure; Muscle Activity; Hypertonia, Muscle; General Relaxation
• Interventions: Device: uninflated air splint; Device: intermittent deep pressure applied by an air splint; Device: constant deep pressure applied by an air splint; Other: contralateral movement

• Registration Number: NCT04188769
• Lead Sponsor: University Ghent

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2019-11-26
• Study Start: 2019-12
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-06
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• subacute stroke (<6 months)
• hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
uninflated - rest	uninflated air splint	splint around the arm is not inflated both arms are in rest during the entire trial
intermittently inflated - rest	intermittent deep pressure applied by an air splint	splint around the arm is intermittently inflated both arms are in rest during the entire trial
intermittently inflated - triggered	intermittent deep pressure applied by an air splint	splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
intermittently inflated - triggered	contralateral movement	splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
constantly inflated - triggered	constant deep pressure applied by an air splint	splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
uninflated - triggered	contralateral movement	splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
uninflated - triggered	uninflated air splint	splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
constantly inflated - triggered	contralateral movement	splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
constantly inflated - rest	constant deep pressure applied by an air splint	splint around the arm is constantly inflated both arms are in rest during the entire trial

Primary Outcome Measures

Name	Time	Method
MyotonPRO measurement of pectoralis major muscle tone	through study completion, an average of 5 months	MyotonPRO measurement of pectoralis major muscle tone
heart rate	through study completion, an average of 5 months	heart rate measurement assessed with the Zehpyr bioharness
heart rate variability	through study completion, an average of 5 months	heart rate variability assessed with the Zehpyr bioharness
EMG of biceps brachii	through study completion, an average of 5 months	electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side
respiratory rate	through study completion, an average of 5 months	respiratory rate assessed with the Zehpyr bioharness
EMG of triceps brachii	through study completion, an average of 5 months	electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side
EMG of pectoralis major	through study completion, an average of 5 months	electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side
subjective rating of hypertonia	through study completion, an average of 5 months	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)

Secondary Outcome Measures

Name	Time	Method
MyotonPRO measurement of pectoralis major elasticity	through study completion, an average of 5 months	MyotonPRO measurement of pectoralis major elasticity
MyotonPRO measurement of pectoralis major stiffness	through study completion, an average of 5 months	MyotonPRO measurement of pectoralis major stiffness

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Belgium