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

Study Overview
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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).

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

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

Intervention / Treatment
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* Device: constant deep pressure applied by an air splint
* Device: intermittent deep pressure applied by an air splint
* Device: uninflated air splint
* Other: contralateral movement


Participation Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: uninflated - rest<br>splint around the arm is not inflated both arms are in rest during the entire trial | Device: uninflated air splint<br>* no deep pressure applied by the air splint<br>|
| Sham Comparator: uninflated - triggered<br>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<br>* no deep pressure applied by the air splint<br>Other: contralateral movement<br>* 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<br>|
| Active Comparator: constantly inflated - rest<br>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<br>* inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm<br>|
| Active Comparator: constantly inflated - triggered<br>splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) | Device: constant deep pressure applied by an air splint<br>* inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm<br>Other: contralateral movement<br>* 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<br>|
| Experimental: intermittently inflated - rest<br>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<br>* continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm<br>|
| Experimental: intermittently inflated - triggered<br>splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) | Device: intermittent deep pressure applied by an air splint<br>* continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm<br>Other: contralateral movement<br>* 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<br>|

What is the study measuring?
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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 |