Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-01 @ 11:09 PM
Study NCT ID:
NCT05278403
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke 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'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized groups. Participants do not know to which group they are assigned. The other participants are unaware of the purpose of the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two randomized groups. A control group and an experimental group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Strength', 'timeFrame': 'One month', 'description': 'Strength measurement using the Daniels and Worthingham Scale. Minimum value = 0 , maximum value = 5. Higher scores mean a better outcome.'}, {'measure': 'Spasticity', 'timeFrame': 'One month', 'description': 'Spasticity measurement using the Ashworth modified scale. Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.'}, {'measure': 'Gait', 'timeFrame': 'One month', 'description': 'Gait measurement using the Tinetti scale. Minimum value = 0, maximum value = 28. Higher scores mean a better outcome.'}, {'measure': 'Balance', 'timeFrame': 'One month', 'description': 'Balance using the Berg Balance Scale. Minimum value = 0, maximum value = 56. Higher scores mean a better outcome.'}, {'measure': 'Joint range', 'timeFrame': 'One month', 'description': 'Joint range measure using goniometer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Virtual Reality', 'Physical Therapy']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial based on the application of virtual reality and video games together with physiotherapy treatment in stroke patients, with the main objective of determining their beneficial effects.', 'detailedDescription': '21 participants who will be divided by randomization between a control group and an experimental group. The results will be quantified with the following scales: Modified Asworth (spasticity). Daniels et al (muscle strength) Tinetti (balance and gait) Berg (balance) Joint range'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients receiving neurological physiotherapy treatment.\n* Patients who have suffered a stroke in the last two years.\n* Patients with an age range between 18 and 80 years old.\n* Patients with stroke with the ability to have minimal manual pressure with one limb.\n\nExclusion Criteria:\n\n* Patients with stroke who also have degenerative diseases such as Alzheimer's or Parkinson's.\n* Stroke patients who do not understand the instructions.\n* Patients who have undergone surgery on the evaluated limbs.\n* Patients with scars that limit movement."}, 'identificationModule': {'nctId': 'NCT05278403', 'briefTitle': 'Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients', 'orgStudyIdInfo': {'id': 'JPV-2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Conventional neurological physiotherapy treatment.', 'interventionNames': ['Other: Neurological physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Conventional neurological physiotherapy treatment with the use of virtual reality and video games.', 'interventionNames': ['Other: Virtual reality and video games', 'Other: Neurological physiotherapy']}], 'interventions': [{'name': 'Virtual reality and video games', 'type': 'OTHER', 'description': "Use of a software in stroke patients' rehabilitation.", 'armGroupLabels': ['Experimental group']}, {'name': 'Neurological physiotherapy', 'type': 'OTHER', 'description': 'Application of conventional physical therapy techniques.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300100', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Universidad de Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'overallOfficials': [{'name': 'Angel Martínez Carrasco, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Murcia'}, {'name': 'Francisco Javier Peláez Vélez, Graduated', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Murcia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Phd', 'investigatorFullName': 'Angel Martínez Carrasco', 'investigatorAffiliation': 'Universidad de Murcia'}}}}