Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date November 2021
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Withdrawn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)

Study Design


Intervention

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
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
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

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis