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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04188769
Other study ID # EC/2019/1776
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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)

Study Design


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
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