Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-02 @ 9:06 AM
Study NCT ID:
NCT04188769
Status:
WITHDRAWN
Last Update Posted:
2021-12-08
First Post:
2019-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of time', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EMG of biceps brachii', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'electromyographic frequency analysis of biceps brachii muscle activity at the hemiplegic side'}, {'measure': 'EMG of triceps brachii', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'electromyographic frequency analysis of triceps brachii muscle activity at the hemiplegic side'}, {'measure': 'EMG of pectoralis major', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'electromyographic frequency analysis of pectoralis major muscle activity at the hemiplegic side'}, {'measure': 'MyotonPRO measurement of pectoralis major muscle tone', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'MyotonPRO measurement of pectoralis major muscle tone'}, {'measure': 'heart rate', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'heart rate measurement assessed with the Zehpyr bioharness'}, {'measure': 'heart rate variability', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'heart rate variability assessed with the Zehpyr bioharness'}, {'measure': 'respiratory rate', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'respiratory rate assessed with the Zehpyr bioharness'}, {'measure': 'subjective rating of hypertonia', 'timeFrame': 'through study completion, an average of 5 months', '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)'}], 'secondaryOutcomes': [{'measure': 'MyotonPRO measurement of pectoralis major elasticity', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'MyotonPRO measurement of pectoralis major elasticity'}, {'measure': 'MyotonPRO measurement of pectoralis major stiffness', 'timeFrame': 'through study completion, an average of 5 months', 'description': 'MyotonPRO measurement of pectoralis major stiffness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Pressure', 'Muscle Activity', 'General Relaxation', 'Stroke', 'Hypertonia, Muscle']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subacute stroke (\\<6 months)\n* hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)'}, 'identificationModule': {'nctId': 'NCT04188769', 'briefTitle': 'Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke', 'orgStudyIdInfo': {'id': 'EC/2019/1776'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'uninflated - rest', 'description': 'splint around the arm is not inflated both arms are in rest during the entire trial', 'interventionNames': ['Device: uninflated air splint']}, {'type': 'SHAM_COMPARATOR', 'label': 'uninflated - triggered', 'description': 'splint around the arm is not inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)', 'interventionNames': ['Device: uninflated air splint', 'Other: contralateral movement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'constantly inflated - rest', 'description': 'splint around the arm is constantly inflated both arms are in rest during the entire trial', 'interventionNames': ['Device: constant deep pressure applied by an air splint']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'constantly inflated - triggered', 'description': 'splint around the arm is constantly inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)', 'interventionNames': ['Device: constant deep pressure applied by an air splint', 'Other: contralateral movement']}, {'type': 'EXPERIMENTAL', 'label': 'intermittently inflated - rest', 'description': 'splint around the arm is intermittently inflated both arms are in rest during the entire trial', 'interventionNames': ['Device: intermittent deep pressure applied by an air splint']}, {'type': 'EXPERIMENTAL', 'label': 'intermittently inflated - triggered', 'description': 'splint around the arm is intermittently inflated 5x flexion and extension with the contralateral arm (with weight of 5kg in the hands)', 'interventionNames': ['Device: intermittent deep pressure applied by an air splint', 'Other: contralateral movement']}], 'interventions': [{'name': 'constant deep pressure applied by an air splint', 'type': 'DEVICE', 'description': 'inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm', 'armGroupLabels': ['constantly inflated - rest', 'constantly inflated - triggered']}, {'name': 'intermittent deep pressure applied by an air splint', 'type': 'DEVICE', 'description': 'continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm', 'armGroupLabels': ['intermittently inflated - rest', 'intermittently inflated - triggered']}, {'name': 'uninflated air splint', 'type': 'DEVICE', 'description': 'no deep pressure applied by the air splint', 'armGroupLabels': ['uninflated - rest', 'uninflated - triggered']}, {'name': 'contralateral movement', 'type': 'OTHER', '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', 'armGroupLabels': ['constantly inflated - triggered', 'intermittently inflated - triggered', 'uninflated - triggered']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}