Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06332794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Keep On Keep Up for Parkinson's
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability of the KOKU app', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Participants will be asked to complete questionnaires about the usability of the KOKU app and participate in an interview based on their responses to the questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Executive clock drawing task (CLOX 1, 2) (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'A clock drawing task (CLOX) designed to elicit executive impairment and discriminate it from non-executive constructional failure.'}, {'measure': 'Trail Making Test (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Timed written test of visual function and scanning'}, {'measure': 'Freezing of Gait Questionnaire (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Self-report questionnaire'}, {'measure': 'Falls Efficacy scale (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Self-report questionnaire (minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)'}, {'measure': "Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline)", 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'The 39 item questionnaire offers a patient reported measure of health status and quality of life. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100 = more health problems).'}, {'measure': 'Mini-BESTest (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': "The Mini-BESTest is a clinical balance test that has shown a high sensitivity in detecting balance impairments in elderly people with Parkinson's disease. The Mini- BESTest consists of 14 items, with a maximum (best) score of 28 points."}, {'measure': 'Two minute walk test, single and dual task (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Participant walks continually for 2 minutes; for dual task, participant is asked to recall numbers as they are walking'}, {'measure': 'EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Self-report quality fo life questionnaire - EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.'}, {'measure': 'Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': "The Activities-specific Balance confidence (ABS) scale is a questionnaire developed to assess older individual's balance confidence in performing daily activities. There are 16 items, representing daily activities. Participants are asked to answer, with a score from 0% (not confident at all) to 100% (completely confident) in increments of 10%, how confident they are in performing each activity. The average score obtained is an indication on balance confidence.\n\nA score of \\> 80% indicates high level of functioning. A score of 50%-80% indicates moderate level of functioning. A score of \\< 50% indicates low levels of functioning. Additionally, a score of \\< 67% suggests substantial risk of falling."}, {'measure': 'Multidimensional Fatigue Inventory (MFI) (mean Change from baseline)', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'The MFI is a 20-item inventory scored on a 5-point Likert scale and measures five dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI dimension scores range from 4 to 20 (most severe) and have been credited with reliably measuring fatigue severity in each dimension.'}, {'measure': 'Technology Acceptance questionnaire', 'timeFrame': 'After 4 weeks of using KOKU at home', 'description': 'Self-report questionnaire, based on the Technology Acceptance Model. There are 15 items which participants have to rate on a scale of 1 (= strongly disagree) to 7 (strongly agree).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Falls prevention', 'Technology', 'Physical activity', 'Co-design'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).\n\nThe main aims of the study are to:\n\n1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.\n2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.\n\nParticipants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app.", 'detailedDescription': 'Keep on Keep Up (KOKU) is a digital program available on a tablet that has been designed to engage people in safe and effective falls prevention exercises. KOKU incorporates evidence-based exercise programmes for balance and function and has demonstrated high usability and acceptability in older adults. KOKU is approved by NHS Digital as compliant with regulatory data and safety standards.\n\nEarlier work by the research team has shown that KOKU is effective in improving balance in older adults. However, the effectiveness of KOKU in PD is unknown. The purpose of this study is to explore if app-based exercise is feasible, acceptable and effective in PD, especially in harder-to-reach populations who may not exercise on a regular basis.\n\nThrough mixed methods approaches, the proposed study aims to: (i) explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective and (ii) produce a KOKU4PD digital program that is ready for NHS approval and a future effectiveness evaluation.\n\n20 people with PD will be recruited to take part in the study where they will be asked to use the KOKU app independently at home for 4 weeks. A repeated measure design will be employed with assessments performed at the clinical gait lab during two separate sessions lasting between 2-3 hours. Participants will attend the lab for outcomes to be measured at the start and after 4 weeks of exercise with the KOKU app. During the second lab visit, participants will complete a questionnaire about the usability of the KOKU app and take part in an interview to explore their experiences of using it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria (H\\&Y stage I-III)\n* Able to walk and stand without support or assistance from another person\n* \\>40 years\n* Stable medication for the previous 1 month and anticipated over a period of 6 months.\n* Adequate vision and hearing - to watch and use an iPad or Tablet.Aim: To define the study population/sample\n\nExclusion Criteria:\n\n* Dementia (\\<21 on Montreal Cognitive Assessment (MoCA) or as diagnosed according to the Movement Disorder Society guidelines\n* Orthopaedic or cardiothoracic ailments that preclude safe walking\n* Severe auditory or visual impairment,\n* Diagnosis of clinical depression"}, 'identificationModule': {'nctId': 'NCT06332794', 'acronym': 'KOKU4PD', 'briefTitle': "Keep On Keep Up for Parkinson's", 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': "Keep On Keep Up (KOKU4PD) - Developing an App for People With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'H-2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KOKU user', 'description': 'SIngle arm study - all participants will use the KOKU app for 4 weeks.', 'interventionNames': ['Device: KOKU4PD']}], 'interventions': [{'name': 'KOKU4PD', 'type': 'DEVICE', 'description': 'Exercise at home using the KOKU app for 4 weeks.', 'armGroupLabels': ['KOKU user']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'state': 'Tyne & Wear', 'country': 'United Kingdom', 'contacts': [{'name': 'Gill Barry, PhD', 'role': 'CONTACT', 'email': 'gill.barry@northumbria.ac.uk', 'phone': '01912277635'}, {'name': 'Julia Das', 'role': 'CONTACT', 'email': 'julia.das@northumbria.ac.uk', 'phone': '01912373343'}], 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will only be available to members of the study team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}, {'name': 'Northumbria Healthcare NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Newcastle University', 'class': 'OTHER'}, {'name': 'Reason Digital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}