Back to resultsEffect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
Primary Purpose
Deep Pressure, Muscle Activity, General Relaxation
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
constant deep pressure applied by an air splint
intermittent deep pressure applied by an air splint
uninflated air splint
contralateral movement
Sponsored by
About this trial
This is an interventional treatment trial for Deep Pressure
Eligibility Criteria
Inclusion Criteria:
- subacute stroke (<6 months)
- hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)
Sites / Locations
- Ghent University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Sham Comparator
Sham Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
uninflated - rest
uninflated - triggered
constantly inflated - rest
constantly inflated - triggered
intermittently inflated - rest
intermittently inflated - triggered
Arm Description
splint around the arm is not inflated both arms are in rest during the entire trial
splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
splint around the arm is constantly inflated both arms are in rest during the entire trial
splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
splint around the arm is intermittently inflated both arms are in rest during the entire trial
splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
Outcomes
Primary Outcome Measures
EMG of biceps brachii
electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side
EMG of triceps brachii
electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side
EMG of pectoralis major
electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side
MyotonPRO measurement of pectoralis major muscle tone
MyotonPRO measurement of pectoralis major muscle tone
heart rate
heart rate measurement assessed with the Zehpyr bioharness
heart rate variability
heart rate variability assessed with the Zehpyr bioharness
respiratory rate
respiratory rate assessed with the Zehpyr bioharness
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)
Secondary Outcome Measures
MyotonPRO measurement of pectoralis major elasticity
MyotonPRO measurement of pectoralis major elasticity
MyotonPRO measurement of pectoralis major stiffness
MyotonPRO measurement of pectoralis major stiffness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04188769
Brief Title
Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
Official Title
Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
lack of time
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Pressure, Muscle Activity, General Relaxation, Stroke, Hypertonia, Muscle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
uninflated - rest
Arm Type
Sham Comparator
Arm Description
splint around the arm is not inflated both arms are in rest during the entire trial
Arm Title
uninflated - triggered
Arm Type
Sham Comparator
Arm Description
splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
Arm Title
constantly inflated - rest
Arm Type
Active Comparator
Arm Description
splint around the arm is constantly inflated both arms are in rest during the entire trial
Arm Title
constantly inflated - triggered
Arm Type
Active Comparator
Arm Description
splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
Arm Title
intermittently inflated - rest
Arm Type
Experimental
Arm Description
splint around the arm is intermittently inflated both arms are in rest during the entire trial
Arm Title
intermittently inflated - triggered
Arm Type
Experimental
Arm Description
splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
Intervention Type
Device
Intervention Name(s)
constant deep pressure applied by an air splint
Intervention Description
inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm
Intervention Type
Device
Intervention Name(s)
intermittent deep pressure applied by an air splint
Intervention Description
continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm
Intervention Type
Device
Intervention Name(s)
uninflated air splint
Intervention Description
no deep pressure applied by the air splint
Intervention Type
Other
Intervention Name(s)
contralateral movement
Intervention Description
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
Primary Outcome Measure Information:
Title
EMG of biceps brachii
Description
electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side
Time Frame
through study completion, an average of 5 months
Title
EMG of triceps brachii
Description
electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side
Time Frame
through study completion, an average of 5 months
Title
EMG of pectoralis major
Description
electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side
Time Frame
through study completion, an average of 5 months
Title
MyotonPRO measurement of pectoralis major muscle tone
Description
MyotonPRO measurement of pectoralis major muscle tone
Time Frame
through study completion, an average of 5 months
Title
heart rate
Description
heart rate measurement assessed with the Zehpyr bioharness
Time Frame
through study completion, an average of 5 months
Title
heart rate variability
Description
heart rate variability assessed with the Zehpyr bioharness
Time Frame
through study completion, an average of 5 months
Title
respiratory rate
Description
respiratory rate assessed with the Zehpyr bioharness
Time Frame
through study completion, an average of 5 months
Title
subjective rating of hypertonia
Description
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)
Time Frame
through study completion, an average of 5 months
Secondary Outcome Measure Information:
Title
MyotonPRO measurement of pectoralis major elasticity
Description
MyotonPRO measurement of pectoralis major elasticity
Time Frame
through study completion, an average of 5 months
Title
MyotonPRO measurement of pectoralis major stiffness
Description
MyotonPRO measurement of pectoralis major stiffness
Time Frame
through study completion, an average of 5 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subacute stroke (<6 months)
hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)
Facility Information:
Facility Name
Ghent University
City
Ghent
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
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