Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT03284606
Status:
TERMINATED
Last Update Posted:
2022-06-16
First Post:
2017-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Recruitment default', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'voluntary muscularity', 'timeFrame': 'Week 10', 'description': 'voluntary muscularity measured by the quotation of Held and Pierrot Deseilligny'}], 'secondaryOutcomes': [{'measure': 'Spasticity score', 'timeFrame': 'Week 10', 'description': 'Ashworth scale modified for spasticity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemiplegia']}, 'descriptionModule': {'briefSummary': "A majority of people undergoing rehabilitation following a stroke have a deficit of the dorsal flexors of the foot. The implementation of rehabilitation techniques in accordance with the recommendations of learned societies is not sufficient to compensate for this deficit. Also Kinesio Taping's method of Dr. Kenzo Kase has caught our attention by its action on muscle, joint, circulatory and pain functions.\n\nThe use of taping would increase the duration of stimulation of the muscles of the dorsiflexors of the foot which would facilitate the motor recovery.\n\nData from the literature do not support the conclusion that taping is effective, but no studies evaluating the efficacy of this technique in the foot-lift deficiency of the hemiplegic patient have been found.\n\nThe investigators hypothesize that the use of taping in conjunction with common rehabilitation for hemiplegic patients following a stroke improves the stimulation of the muscles of the dorsiflexors of the foot with a positive impact on the walking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with a stroke occurring in a period ranging from 15 days to a month before inclusion and presenting left or right hemiplegia.\n* Voluntary motricity of the dorsal flexors of the foot greater than or equal to 1 on the scale of Held and Pierrot Deseilligny\n* Quadriceps voluntary motor skill greater than or equal to 2 on the scale of Held and Pierrot Deseilligny\n* Informed consent of the patient.\n\nExclusion Criteria:\n\n* \\- Evolutive neurological disease leading to cognitive impairment (Alzheimer's, Parkinson's, Multiple sclerosis ...)\n* Pre-stroke neurological sequelae\n* Achilles tendon elongation or tendinous transfer surgery.\n* Spasticity of the sural triceps greater than 2 on the modified Ashworth scale\n* Injection of botulinum toxin\n* Patients under guardianship, curatorships or under safeguard of justice.\n* Allergy to glue, skin lesions located on the zone of laying of the bands\n* Complex Regional Pain Symptom of the Ankle"}, 'identificationModule': {'nctId': 'NCT03284606', 'acronym': 'NEUROTAP', 'briefTitle': 'Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'A Pilot Study of the Effect of Taping in the Hemiplegic Patient With a Deficit of the Footbrowers', 'orgStudyIdInfo': {'id': 'RC31/15/7839'}, 'secondaryIdInfos': [{'id': '2016-A01552-49', 'type': 'REGISTRY', 'domain': 'French ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAPING', 'description': 'taping in conjunction with common rehabilitation for hemiplegic patients', 'interventionNames': ['Device: TAPING', 'Procedure: Common rehabilitation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NO TAPING', 'description': 'Common rehabilitation for hemiplegic patients without taping', 'interventionNames': ['Procedure: Common rehabilitation']}], 'interventions': [{'name': 'TAPING', 'type': 'DEVICE', 'description': 'Taping in conjunction with common rehabilitation for hemiplegic patients', 'armGroupLabels': ['TAPING']}, {'name': 'Common rehabilitation', 'type': 'PROCEDURE', 'description': 'Common rehabilitation for hemiplegic patients', 'armGroupLabels': ['NO TAPING', 'TAPING']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31052', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Aurélie MORIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': "Groupement Interrégional de Recherche Clinique et d'Innovation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}