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

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

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.

Study Overview

• Status: Withdrawn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

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: uninflated - rest; splint around the arm is not inflated both arms are in rest during the entire trial	Device: uninflated air splint; no deep pressure applied by the air splint
Sham Comparator: uninflated - triggered; splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)	Device: 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
Active Comparator: constantly inflated - rest; splint around the arm is constantly inflated both arms are in rest during the entire trial	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
Active Comparator: constantly inflated - triggered; splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)	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; 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
Experimental: intermittently inflated - rest; splint around the arm is intermittently inflated both arms are in rest during the entire trial	Device: 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
Experimental: intermittently inflated - triggered; splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)	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; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMG of biceps brachii	electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side	through study completion, an average of 5 months
EMG of triceps brachii	electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side	through study completion, an average of 5 months
EMG of pectoralis major	electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side	through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major muscle tone	MyotonPRO measurement of pectoralis major muscle tone	through study completion, an average of 5 months
heart rate	heart rate measurement assessed with the Zehpyr bioharness	through study completion, an average of 5 months
heart rate variability	heart rate variability assessed with the Zehpyr bioharness	through study completion, an average of 5 months
respiratory rate	respiratory rate assessed with the Zehpyr bioharness	through study completion, an average of 5 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MyotonPRO measurement of pectoralis major elasticity	MyotonPRO measurement of pectoralis major elasticity	through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major stiffness	MyotonPRO measurement of pectoralis major stiffness	through study completion, an average of 5 months

Collaborators and Investigators

• Sponsor: University Ghent

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Stroke; Muscle Hypertonia
• Other Study ID Numbers: EC/2019/1776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No