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

NCT ID: NCT04188769

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-04-30

Brief Summary

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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

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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).

Conditions

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Deep Pressure Muscle Activity General Relaxation Stroke Hypertonia, Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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uninflated - rest

splint around the arm is not inflated both arms are in rest during the entire trial

Group Type SHAM_COMPARATOR

uninflated air splint

Intervention Type DEVICE

no deep pressure applied by the air splint

uninflated - triggered

splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)

Group Type SHAM_COMPARATOR

uninflated air splint

Intervention Type DEVICE

no deep pressure applied by the air splint

contralateral movement

Intervention Type OTHER

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

constantly inflated - rest

splint around the arm is constantly inflated both arms are in rest during the entire trial

Group Type ACTIVE_COMPARATOR

constant deep pressure applied by an air splint

Intervention Type DEVICE

inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm

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)

Group Type ACTIVE_COMPARATOR

constant deep pressure applied by an air splint

Intervention Type DEVICE

inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm

contralateral movement

Intervention Type OTHER

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

intermittently inflated - rest

splint around the arm is intermittently inflated both arms are in rest during the entire trial

Group Type EXPERIMENTAL

intermittent deep pressure applied by an air splint

Intervention Type DEVICE

continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm

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)

Group Type EXPERIMENTAL

intermittent deep pressure applied by an air splint

Intervention Type DEVICE

continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm

contralateral movement

Intervention Type OTHER

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

Interventions

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constant deep pressure applied by an air splint

inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm

Intervention Type 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

Intervention Type DEVICE

uninflated air splint

no deep pressure applied by the air splint

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghent University

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC/2019/1776

Identifier Type: -

Identifier Source: org_study_id