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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04188769
Enrollment
0
Registered
2019-12-06
Start date
2019-12-31
Completion date
2020-04-30
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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).

Interventions

DEVICEconstant deep pressure applied by an air splint

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

DEVICEintermittent 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

DEVICEuninflated air splint

no deep pressure applied by the air splint

OTHERcontralateral 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

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
subjective rating of hypertoniathrough study completion, an average of 5 monthsvisual 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)
heart rate variabilitythrough study completion, an average of 5 monthsheart rate variability assessed with the Zehpyr bioharness
respiratory ratethrough study completion, an average of 5 monthsrespiratory rate assessed with the Zehpyr bioharness
EMG of biceps brachiithrough study completion, an average of 5 monthselectromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side
EMG of triceps brachiithrough study completion, an average of 5 monthselectromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side
EMG of pectoralis majorthrough study completion, an average of 5 monthselectromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side
MyotonPRO measurement of pectoralis major muscle tonethrough study completion, an average of 5 monthsMyotonPRO measurement of pectoralis major muscle tone
heart ratethrough study completion, an average of 5 monthsheart rate measurement assessed with the Zehpyr bioharness

Secondary

MeasureTime frameDescription
MyotonPRO measurement of pectoralis major elasticitythrough study completion, an average of 5 monthsMyotonPRO measurement of pectoralis major elasticity
MyotonPRO measurement of pectoralis major stiffnessthrough study completion, an average of 5 monthsMyotonPRO measurement of pectoralis major stiffness

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026