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

November 25, 2021 updated by: University Ghent

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Ghent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: uninflated - rest
splint around the arm is not inflated both arms are in rest during the entire trial
Device: uninflated air splint
no deep pressure applied by the air splint
Sham Comparator: uninflated - triggered
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
no deep pressure applied by the air splint
Other: contralateral 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
Active Comparator: constantly inflated - rest
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
inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm
Active Comparator: constantly inflated - triggered
splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
Other: contralateral 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
Device: constant deep pressure applied by an air splint
inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm
Experimental: intermittently inflated - rest
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
continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm
Experimental: intermittently inflated - triggered
splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)
Other: contralateral 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
Device: intermittent 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 5 months
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
through study completion, an average of 5 months
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
through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major muscle tone
Time Frame: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major muscle tone
through study completion, an average of 5 months
heart rate
Time Frame: through study completion, an average of 5 months
heart rate measurement assessed with the Zehpyr bioharness
through study completion, an average of 5 months
heart rate variability
Time Frame: through study completion, an average of 5 months
heart rate variability assessed with the Zehpyr bioharness
through study completion, an average of 5 months
respiratory rate
Time Frame: through study completion, an average of 5 months
respiratory rate assessed with the Zehpyr bioharness
through study completion, an average of 5 months
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)
through study completion, an average of 5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MyotonPRO measurement of pectoralis major elasticity
Time Frame: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major elasticity
through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major stiffness
Time Frame: through study completion, an average of 5 months
MyotonPRO measurement of pectoralis major stiffness
through study completion, an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC/2019/1776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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