Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-07 @ 12:41 AM
Study NCT ID:
NCT06952595
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2025-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carer Involvement in Exercises for People With Acquired Brain Injury.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Log of exercise repetitions', 'timeFrame': 'Pre and post intervention: 4 weeks or at point of discharge from acute Trust.', 'description': 'Log of exercise repetitions completed by patient and relative/carer team (on exercise record log), VAS score (Visual analogue score) rating 0- no confidence to 10- very confident for carer confidence pre and post intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stoke', 'Acquired brain injury', 'rehabilitation', 'exercise therapy'], 'conditions': ['Acquired Brain Injury (Including Stroke)']}, 'descriptionModule': {'briefSummary': 'Increasing the amount of exercises completed has been shown to help recovery for people after a brain injury. This study will explore if providing extra training of exercises prescribed to a patient and carer team, will allow more practice of these exercises, better abilities to move and balance, and to assess if carer confidence changes with doing this. It is a repeated case design in the in-patient acute Neurosciences setting at the Norfolk and Norwich University Hospital NHS Trust (NNUH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion\n\n* Adults with acquired brain injury on NNUH Neurosciences Unit with a carer physically able to complete exercises with the patient.\n* Patient to be able to follow simple commands (1 stage) for exercise intervention.\n* Patient able to consent along with their relative together to participation in the study.\n\nExclusion:\n\n* Discharge plan for ESD from initial assessment with no care package required due to too short timeframe of being an acute in-patient.\n* Patient's with severe cognitive - communication deficits meaning they cannot follow 1 stage command for exercises or consent to the study.\n* Severe pain, joint abnormality or spasticity limiting participation in exercise programme.\n* Carer/relative not able to physically help the patient with the required exercises or carer/relative not able to consent to the study."}, 'identificationModule': {'nctId': 'NCT06952595', 'briefTitle': 'Carer Involvement in Exercises for People With Acquired Brain Injury.', 'organization': {'class': 'OTHER', 'fullName': 'Norfolk and Norwich University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Carer Involvement in Exercise Programmes for Acute Neurosciences Patients With Acquired Brain Injury', 'orgStudyIdInfo': {'id': '334551 (196-10-23)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercises for people with acquired brain injury', 'interventionNames': ['Behavioral: five exercises prescribed and taught to carers and participants']}], 'interventions': [{'name': 'five exercises prescribed and taught to carers and participants', 'type': 'BEHAVIORAL', 'description': 'Up to five exercises prescribed and taught to carers and participants in an acute hospital setting fort hem to continue to practice as able.', 'armGroupLabels': ['Exercises for people with acquired brain injury']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of East Anglia', 'class': 'OTHER'}, {'name': '3 Million Steps charity', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}