Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-29 @ 9:00 PM
Study NCT ID:
NCT06048432
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2022-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-physiotherapy on Post-stroke Hemiplegia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy or with physiotherapy plus telecare.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy (CONTROL) or with physiotherapy plus telecare (INTERVENTION).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2022-08-07', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in muscle activity', 'timeFrame': 'Determinations will be done through study completion, an average of 1 year.', 'description': 'Main outcome will be changes in electromyogrpahic activity. A change of plus 10 microvolts will be considered as an effective intervention.'}], 'secondaryOutcomes': [{'measure': 'Fugl-Meyer test score', 'timeFrame': 'Determinations will be done through study completion, an average of 1 year', 'description': 'Changes in the specific functional capacity of stroke patients will be determined by the Fugl-Meyer test. A change greater than 10% will be considered beneficial. The Fugl-Meyer test score ranges from 0-66. Higher scores represent better functionality (further information at: PMID: 1135616).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemiplegia', 'stroke', 'telephyisiotherapy', 'older adults'], 'conditions': ['Hemiplegia', 'Muscle Spasticity']}, 'referencesModule': {'references': [{'pmid': '31511629', 'type': 'BACKGROUND', 'citation': 'Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.'}, {'pmid': '35378544', 'type': 'BACKGROUND', 'citation': 'Gamez Santiago AB, Martinez Caceres CM, Hernandez-Morante JJ. Effectiveness of Intensively Applied Mirror Therapy in Older Patients with Post-Stroke Hemiplegia: A Preliminary Trial. Eur Neurol. 2022;85(4):291-299. doi: 10.1159/000522413. Epub 2022 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The present preliminary randomized trial will be performed to compare the effectiveness of telephyisiotherapy plus physical exercises versus other conventional techniques (electromyographic biofeedback or conventional physiotherapy).\n\nParticipants will be chosen from Hospital Sagrado Corazón de Málaga, after the approval of the centre. One hundred and twenty patients with hemiplegia as a consequence of an ischaemic stroke will take part in the study. Selection criteria included to be older than 65 years, with two months of evolution after the stroke and with the left paretic side. In addition, they had to have a positive diagnosis of COVID-19. Positive cases will be confirmed by PCR. Due to the local sanitary regulations, all patients may require home confinement during 1 month without possibility to continue their rehabilitation program.\n\nPhysiological interventions started 20 days after the first negative PCR test.\n\nParticipants will be randomize in three different intervention groups, conventional therapy (n=40), carried out in the Hospital, biofeedback therapy (n=40), also conducted in the Hospital, and Telephyisiotherapy (TP) plus physical activity (n=40). The intervention period will last for three months, and participants will be re-evaluated 30 days later to confirm treatment effectiveness.\n\nMeasurements\n\nElectromyographic activity and hand strength The mean electromyographic (EMG) activity will be determined with the Neurotrans Myoplus 2 Pro System (Verity Medical Ltd, UK), the same instrument used to carry out the intervention. The isometric strength (Nw) of the hand will be assessed with a hand-held digital dynamometer (Smedley digital hand dynamometer, RMS Ltd., UK).\n\nFunctional tests In the present work, the Fugl-Meyer will be used to determine the functional status of patients with stroke. The patients with better functionality had superior scores. In addition, the ability of the patients to perform basic daily living activities was determined through the Barthel index. Considering the advanced age of the participants, three extra-scales will be determined: the FRAIL scale, the short physical performance battery (SPPB) and the Strength, assistance in walking, rise from a chair, climb stairs and falls (SARC-F) scale will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hemiplegia as a consequence of an ischaemic stroke\n* To be older than 65 years\n* Voluntarily participate in the study\n\nExclusion Criteria:\n\n* To suffer from dementia or severe cognitive decline\n* To have any specific contraindication for sport practice (as suffering from joint pain, etc.)\n* Those with any diagnosis of severe pathology (cancer, cardiovascular event, etc.) during the study period.'}, 'identificationModule': {'nctId': 'NCT06048432', 'briefTitle': 'Tele-physiotherapy on Post-stroke Hemiplegia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica San Antonio de Murcia'}, 'officialTitle': 'Effect of Tele-physiotherapy on Patients With Post-stroke Hemiplegia During covid19 Lockdown', 'orgStudyIdInfo': {'id': 'TELEFISIO-ON-COVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Conventional phyisiotherapy + telecare', 'interventionNames': ['Other: Conventional Physiotherapy + telephysiotherapty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Conventional physiotherapy', 'interventionNames': ['Other: Conventional Physiotherapy + telephysiotherapty']}], 'interventions': [{'name': 'Conventional Physiotherapy + telephysiotherapty', 'type': 'OTHER', 'description': 'Patients assigned to the telephyisiotherapy (TP) group will carry out a half-hour session of conventional therapy, plus a 1-hour session of physical exercise, which will be carried out through the administration of tutorial videos, telephone instructions or by email.', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30107', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Catholic University of Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Juan José Hernández Morante, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Católica San Antonio de Murcia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'IPD will be posted online in a public repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica San Antonio de Murcia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hermanas Hospitalarias del Sagrado Corazón de Jesús', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Juan Jose Hernández Morante', 'investigatorAffiliation': 'Universidad Católica San Antonio de Murcia'}}}}