Deep PressureNCT04188769
Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
A study testing constant deep pressure applied by an air splint, intermittent deep pressure applied by an air splint and uninflated air splint in people with Deep Pressure and Muscle Activity, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Pressure, Muscle Activity, General Relaxation
- What is being tested?
- constant deep pressure applied by an air splint, intermittent deep pressure applied by an air splint and uninflated air splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- subacute stroke (<6 months)
- hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
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.
Read the 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).
- Conditions
- Deep Pressure, Muscle Activity, General Relaxation, Stroke, Hypertonia, Muscle
- Being tested
- constant deep pressure applied by an air splint, intermittent deep pressure applied by an air splint, uninflated air splint, contralateral movement
- Medical subject headings
- Stroke, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constant deep pressure applied by an air splintDevice
inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm
intermittent deep pressure applied by an air splintDevice
continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm
uninflated air splintDevice
no deep pressure applied by the air splint
contralateral movementOther
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
| Study group | Role | What they receive |
|---|---|---|
| uninflated - rest | Sham comparator | splint around the arm is not inflated both arms are in rest during the entire trial Receives: Device: uninflated air splint |
| uninflated - triggered | Sham comparator | splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) Receives: Device: uninflated air splint; Other: contralateral movement |
| constantly inflated - rest | Active comparator | splint around the arm is constantly inflated both arms are in rest during the entire trial Receives: Device: constant deep pressure applied by an air splint |
| constantly inflated - triggered | Active comparator | splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) Receives: Device: constant deep pressure applied by an air splint; Other: contralateral movement |
| intermittently inflated - rest | Experimental | splint around the arm is intermittently inflated both arms are in rest during the entire trial Receives: Device: intermittent deep pressure applied by an air splint |
| intermittently inflated - triggered | Experimental | splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) Receives: Device: intermittent deep pressure applied by an air splint; Other: contralateral movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG of biceps brachii
electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side
Measured: through study completion, an average of 5 months
EMG of triceps brachii
electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side
Measured: through study completion, an average of 5 months
EMG of pectoralis major
electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side
Measured: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major muscle tone
MyotonPRO measurement of pectoralis major muscle tone
Measured: through study completion, an average of 5 months
heart rate
heart rate measurement assessed with the Zehpyr bioharness
Measured: through study completion, an average of 5 months
heart rate variability
heart rate variability assessed with the Zehpyr bioharness
Measured: through study completion, an average of 5 months
respiratory rate
respiratory rate assessed with the Zehpyr bioharness
Measured: 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)
Measured: through study completion, an average of 5 months
Secondary outcomes (2)
MyotonPRO measurement of pectoralis major elasticity
MyotonPRO measurement of pectoralis major elasticity
Measured: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major stiffness
MyotonPRO measurement of pectoralis major stiffness
Measured: through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: lack of time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep PressureStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188769
- Sponsor's protocol ID
- EC/2019/1776
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2019
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
- ClinicalTrials.gov ID
- NCT04188769
- Acronym / sponsor ID
- EC/2019/1776
- Conditions
- Deep Pressure, Muscle Activity, General Relaxation, Stroke, Hypertonia, Muscle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| uninflated - rest | Sham comparator | Device: uninflated air splintsplint around the arm is not inflated both arms are in rest during the entire trial |
| uninflated - triggered | Sham comparator | Device: uninflated air splint, Other: contralateral movementsplint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) |
| constantly inflated - rest | Active comparator | Device: constant deep pressure applied by an air splintsplint around the arm is constantly inflated both arms are in rest during the entire trial |
| constantly inflated - triggered | Active comparator | Device: constant deep pressure applied by an air splint, Other: contralateral movementsplint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) |
| intermittently inflated - rest | Experimental | Device: intermittent deep pressure applied by an air splintsplint around the arm is intermittently inflated both arms are in rest during the entire trial |
| intermittently inflated - triggered | Experimental | Device: intermittent deep pressure applied by an air splint, Other: contralateral movementsplint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- subacute stroke (<6 months)
- hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| constant deep pressure applied by an air splintinflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm | Device | constantly inflated - rest, constantly inflated - triggered |
| intermittent deep pressure applied by an air splintcontinuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm | Device | intermittently inflated - rest, intermittently inflated - triggered |
| uninflated air splintno deep pressure applied by the air splint | Device | uninflated - rest, uninflated - triggered |
| contralateral movementnon-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 | Other | constantly inflated - triggered, intermittently inflated - triggered, uninflated - triggered |
Primary outcome
EMG of biceps brachii
Time frame: through study completion, an average of 5 months
electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side
EMG of triceps brachii
Time frame: through study completion, an average of 5 months
electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side
EMG of pectoralis major
Time frame: through study completion, an average of 5 months
electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side
MyotonPRO measurement of pectoralis major muscle tone
Time frame: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major muscle tone
heart rate
Time frame: through study completion, an average of 5 months
heart rate measurement assessed with the Zehpyr bioharness
heart rate variability
Time frame: through study completion, an average of 5 months
heart rate variability assessed with the Zehpyr bioharness
respiratory rate
Time frame: through study completion, an average of 5 months
respiratory rate assessed with the Zehpyr bioharness
subjective rating of hypertonia
Time frame: through study completion, an average of 5 months
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)
2 secondary outcomes
MyotonPRO measurement of pectoralis major elasticity
Time frame: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major stiffness
Time frame: through study completion, an average of 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing constant deep pressure applied by an air splint, intermittent deep pressure applied by an air splint and uninflated air splint in people with Deep Pressure and Muscle Activity, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG of biceps brachii (time frame: through study completion, an average of 5 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.