Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-27 @ 11:30 PM
Study NCT ID:
NCT04167059
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Support to Increase Physical Activity in Rett Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-25', 'releaseDate': '2023-04-13'}], 'estimatedResultsFirstSubmitDate': '2023-04-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015518', 'term': 'Rett Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'We note that our primary outcomes of sedentary behaviours and physical activity will be measured objectively by physical activity devices.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "We are using a waitlist controlled trial study design. Group membership will be determined using a concealed allocation randomisation after the baseline assessment. The 'immediate treatment' group will receive the 12-week intervention period following the assessment at baseline followed by a 12 week non-intervention period. The 'waitlist control' group receive no intervention in the first 12 week period and will then receive the intervention in the second 12 week period."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-02', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily uptime (%)', 'timeFrame': 'Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks', 'description': 'Percentage of time spent active (uptime) over total awake time, measured with an ActivPAL'}, {'measure': 'Average daily step count', 'timeFrame': 'Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks', 'description': 'Number of daily steps measured by Stepwatch Activity Monitor'}], 'secondaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks', 'description': 'Sleep Disturbance Scale for Children.'}, {'measure': 'Behaviour', 'timeFrame': 'Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks', 'description': 'Rett Syndrome Behaviour Scale'}, {'measure': 'Child Quality of Life', 'timeFrame': 'Parent caregiver recall over previous month, data capture at baseline, after 12 weeks and after 24 weeks', 'description': 'Quality of Life Inventory-Disability (QI-Disability)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedentary behaviour', 'Physical activity', 'Quality of life', 'Telehealth'], 'conditions': ['Rett Syndrome']}, 'referencesModule': {'references': [{'pmid': '33376177', 'type': 'DERIVED', 'citation': 'Downs J, Lotan M, Elefant C, Leonard H, Wong K, Buckley N, Stahlhut M. Implementing telehealth support to increase physical activity in girls and women with Rett syndrome-ActivRett: protocol for a waitlist randomised controlled trial. BMJ Open. 2020 Dec 29;10(12):e042446. doi: 10.1136/bmjopen-2020-042446.'}]}, 'descriptionModule': {'briefSummary': 'This study will recruit families with a daughter with Rett syndrome living in either Australia, Denmark or Israel, and thereafter deliver individually designed participation programs using telehealth strategies. We will evaluate the effectiveness of the programs on reducing sedentary behaviours, increasing physical activity and increasing quality of life.', 'detailedDescription': 'This project will implement two intertwined strategies that will build the capacity of the carer, clinical and therapy communities to support physical activity in Rett syndrome. Individuals with Rett syndrome experience difficulties with movement and this can make it difficult to participate in regular physical activity. Individuals with Rett syndrome need support to participate in physical activities and it is important to work with primary caregivers when developing strategies to support physical activity. We will conduct a clinical trial that tests the effectiveness of working with primary caregivers to develop strategies suitable to their lives that aim to increase participation in physical activity in the individual with Rett syndrome whom they support. We will use a clinical trial design and work with primary caregivers using Telehealth. We will test whether this approach decreases sedentary time and increases physical activity. We will also test if there are changes in the sleep, behaviour and quality of life. We aim to recruit 60 families for this study, 26 of whom will live in Australia. Data from the three sites will be pooled for a stronger analysis. We acknowledge that physical activity can be associated with a fall and therefore our program will be developed with the primary caregiver to be suitable for their lives and capacity to provide support. However, by practicing more activity, the individuals with Rett syndrome could be stronger and risks of falling could be reduced. The risks for the individual with Rett syndrome are therefore low. To let the Rett syndrome community know our results, we will then develop an online resource documenting the physical activity program and the evidence available to support it, and this will be freely available to families, carers and therapists wherever they live in the world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetically confirmed Rett syndrome\n* Able to stand (with or without assistance)\n* Live in Australia, Denmark or Israel\n\nExclusion Criteria:\n\n* Individuals who have had spinal fusion over the previous 12 months\n* Individuals who have had lower extremity orthopaedic surgery over the previous 6 months'}, 'identificationModule': {'nctId': 'NCT04167059', 'acronym': 'ActivRett', 'briefTitle': 'Telehealth Support to Increase Physical Activity in Rett Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Telethon Kids Institute'}, 'officialTitle': 'Implementing Telehealth Support to Increase Physical Activity in Girls and Women With Rett Syndrome', 'orgStudyIdInfo': {'id': 'RGS0000003371'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Waitlist-Control Group', 'description': "The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.", 'interventionNames': ['Behavioral: Telehealth-delivered participation strategies to increase physical activity']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate Treatment', 'description': "The 'immediate treatment' group will receive the 12-week intervention period first, followed by 12 week non-intervention period.", 'interventionNames': ['Behavioral: Telehealth-delivered participation strategies to increase physical activity']}], 'interventions': [{'name': 'Telehealth-delivered participation strategies to increase physical activity', 'type': 'BEHAVIORAL', 'description': 'Therapists and primary caregivers will meet online on 6 occasions at fortnightly intervals over a 12 week period. Sessions will enable the development of strategies that will aim to increase the amount the participant stands and walks. Throughout, the therapists and primary caregivers will discuss physical activity needs, determine relevant activities, modify the program as necessary and plan additional goals.', 'armGroupLabels': ['Immediate Treatment', 'Waitlist-Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Michelle Stahlhut, PhD', 'role': 'CONTACT', 'email': 'michelle.stahlhut@regionh.dk', 'phone': '+45 29 20 48 49'}], 'facility': 'Center for Rett Syndrom, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Ari’el', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Meir Lotan, PhD', 'role': 'CONTACT', 'email': 'ml_pt_rs@013net.net'}], 'facility': "Ari'el University", 'geoPoint': {'lat': 32.10635, 'lon': 35.1892}}], 'centralContacts': [{'name': 'Jenny Downs, PhD', 'role': 'CONTACT', 'email': 'Jenny.Downs@telethonkids.org.au', 'phone': '+61 8 6319 1763'}, {'name': 'Nicholas Buckley, BSc(Hons)', 'role': 'CONTACT', 'email': 'nicholas.buckley@telethonkids.org.au', 'phone': '+61 8 6319 1771'}], 'overallOfficials': [{'name': 'Jenny Downs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Telethon Kids Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telethon Kids Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Ariel University', 'class': 'OTHER'}, {'name': 'University of Haifa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-04-13', 'type': 'RELEASE'}, {'date': '2024-01-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Telethon Kids Institute'}}}}