Stroke Clinical Trial
Official title:
Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
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Status | Withdrawn |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 |
Verified date | November 2021 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
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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