Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT06885294
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-30
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy/hypnosis for AVC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of joint ranges of motion', 'timeFrame': '8 weeks', 'description': 'Measurement of shoulder (flexion, extension, abduction, internal rotation, external rotation), elbow (flexion, extension), wrist (flexion, extension)'}, {'measure': 'assessment of spasticity', 'timeFrame': '8 weeks', 'description': 'Measurement of muscle activation on Ashworth scale (extension and flexion of shoulder, elbow, wrist, fingers, thumb) =\\> 0%-100% (a higher score means a worse outcome)'}, {'measure': 'functional tests for the upper limb', 'timeFrame': '8 weeks', 'description': "Stroke Upper Limb Capacity Scale (SULCS) =\\> 0%-100% (a higher score means a better outcome)\n\n* using one forearm as support while sitting\n* wedging an object between the chest and the upper part of the affected limb\n* sliding an object across a table while sitting\n* partially unscrewing a lid\n* taking a glass of water and drinking it\n* grabbing a tennis ball presented at a certain height\n* coming one's hair with the affected upper limb\n* buttoning\n* writing"}, {'measure': 'scales for assessing disability and functional independence', 'timeFrame': '8 weeks', 'description': 'Functional Independence Measure (FIM) from complete dependence to independence =\\> 0%-100% (a higher score means a better outcome)\n\n* personal care\n* sphincter control\n* mobility, transfers\n* locomotion\n* communication\n* awareness of the external world'}, {'measure': 'evaluation of muscle strength', 'timeFrame': '8 weeks', 'description': 'Measurement of pathological upper limb strength on MRC scale by group/time/joint/movement =\\> 0%-100% (a higher score means a better outcome)\n\n* Shoulder Flexion Strength\n* Shoulder Extension Strength\n* Shoulder Abduction Strength\n* Shoulder Internal Rotation Strength\n* Shoulder External Rotation Strength\n* Elbow Flexion Strength\n* Elbow Extension Strength\n* Wrist Flexion Strength\n* Wrist Extension Strength\n* Finger Flexion Strength\n* Finger Extension Strength\n* Thumb Flexion Strength\n* Thumb Extension Strength'}, {'measure': 'Box and Block Test (BBT)', 'timeFrame': '8 weeks', 'description': 'Measurement of manual dexterity and motor skills by moving blocks into box comparing healthy upper limb with pathological upper limb =\\> 0%-100% (a higher score means a better outcome)'}, {'measure': 'Modified Rankin Scale (mRS)', 'timeFrame': '8 weeks', 'description': 'Measurement of degree of disability =\\> 0%-100% (a higher score means a worse outcome)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypnosis, Stroke, physiotherapy'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Impact of physical therapy with hypnosis on the functional capacity of the upper limb in stroked patients.', 'detailedDescription': "The cerebrovascular accident (CVA) is a pathology generating many disabled people. Physiotherapy is one of the usual rehabilitation techniques for a patient with sequelae of ischemia or cerebral hemorrhage. Combined with another therapeutic approach, hypnosis, it could increase the patient's motor performance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 to 80 years old\n* Having experienced a stroke more than 3 months ago\n* Understanding and proficient in the French language\n* Having a functional capacity deficit in at least one of the two upper limbs\n* Being able to independently travel to the Yerne medical center for necessary study appointments.\n\nExclusion Criteria:\n\n* Being under 18 or over 80 years old\n* Having a history of upper limb injuries (fractures, prosthetics, etc.)\n* Having Wernicke's aphasia (language comprehension disorder)\n* Having frontal lobe syndrome\n* Undergoing chemotherapy\n* Having respiratory disorders (respiratory failure of more than 70%) or receiving oxygen therapy\n* Having epilepsy\n* Having dementia\n* Having untreated hearing impairments\n* Being diagnosed with schizophrenia or paranoïa\n* Experiencing significant concentration difficulties"}, 'identificationModule': {'nctId': 'NCT06885294', 'briefTitle': 'Physiotherapy/hypnosis for AVC Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Impact of Physiotherapy Combined to Hypnosis on Superior Limb Functional Capacities of AVC Patients', 'orgStudyIdInfo': {'id': '2022-306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 receiving physiotherapy only', 'description': 'Stroke patients will receive physiotherapy of upper limbs', 'interventionNames': ['Behavioral: Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 receiving combined physiotherapy and hypnosis', 'description': 'Stroke patients will receive physiotherapy of upper limbs under hypnosis', 'interventionNames': ['Behavioral: Physiotherapy and Hypnosis']}, {'type': 'EXPERIMENTAL', 'label': 'Waitlist group 3 receiving delayed combined physiotherapy and hypnosis', 'description': 'Stroke patients will receive physiotherapy of upper limbs under hypnosis one month after the other groups', 'interventionNames': ['Behavioral: Control group Physiotherapy and Hypnosis']}], 'interventions': [{'name': 'Physiotherapy', 'type': 'BEHAVIORAL', 'description': 'Stroke patients will be randomly assigned to join one of the three groups. The first group will undergo a pre-treatment evaluation, receive 6 sessions of physiotherapy (2 sessions per week, approximately 20-30 minutes each), and undergo a post-treatment evaluation after 1 month. After another month without any treatment, they will undergo a third and final assessment. All evaluations will last approximately 1 hour.', 'armGroupLabels': ['Group 1 receiving physiotherapy only']}, {'name': 'Physiotherapy and Hypnosis', 'type': 'BEHAVIORAL', 'description': 'Stroke patients will be randomly assigned to join one of the three groups. The second group will undergo a pre-treatment evaluation, receive 6 sessions of physiotherapy combined with hypnosis (2 sessions per week, approximately 20-30 minutes each), and undergo a post-treatment evaluation after 1 month. Patients will continue their standard physiotherapy care during these 4 weeks. After another month without any treatment, they will undergo a third and final assessment. All evaluations will last approximately 1 hour.', 'armGroupLabels': ['Group 2 receiving combined physiotherapy and hypnosis']}, {'name': 'Control group Physiotherapy and Hypnosis', 'type': 'BEHAVIORAL', 'description': 'The control group will be assessed initially and then after 4 weeks. After the second assessment, they will receive 6 sessions of physiotherapy combined with hypnosis (2 sessions per week, approximately 20-30 minutes each), and undergo a post-treatment evaluation after 1 month. All evaluation sessions will last approximately 1 hour.', 'armGroupLabels': ['Waitlist group 3 receiving delayed combined physiotherapy and hypnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'GIGA Science and Perception Research Group CHU Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Audrey Vanhaudenhuyse, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Liege'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Audrey Vanhaudenhuyse', 'investigatorAffiliation': 'University of Liege'}}}}