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

University Ghent

Status: Withdrawn

Conditions: Muscle Activity; Hypertonia, Muscle; Stroke; Deep Pressure; General Relaxation

Treatments: Other: contralateral movement; Device: intermittent deep pressure applied by an air splint; Device: constant deep pressure applied by an air splint; Device: uninflated air splint

Study type: Interventional

Funder types: Other

Identifiers

NCT04188769

EC/2019/1776

Details and patient eligibility

About

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.

Full 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).

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 6 patient groups

uninflated - rest

Sham Comparator group

Description:

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

Treatment:

Device: uninflated air splint

uninflated - triggered

Sham Comparator group

Description:

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

Treatment:

Other: contralateral movement

Device: uninflated air splint

constantly inflated - rest

Active Comparator group

Description:

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

Treatment:

Device: constant deep pressure applied by an air splint

constantly inflated - triggered

Active Comparator group

Description:

splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)

Treatment:

Other: contralateral movement

Device: constant deep pressure applied by an air splint

intermittently inflated - rest

Experimental group

Description:

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

Treatment:

Device: intermittent deep pressure applied by an air splint

intermittently inflated - triggered

Experimental group

Description:

splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)

Treatment:

Device: intermittent deep pressure applied by an air splint

Other: contralateral movement