Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-27 @ 6:41 AM
Study NCT ID:
NCT06787768
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2024-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology Enriched Rehabilitation Gym
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking is used'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Two baselines measures of function (mobility) separated by 14 days recorded at least 1 week before the intervention. Intervention is an 8 week rehabilitation programme delivered with technology. Measures of function repeated immediately after intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2024-08-14', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10-meter walk test (10mWT)', 'timeFrame': 'Four time points; 1) Two weeks before intervention starts,2) immediately before the intervention, 3) week 4 (halfway way through intervention) and 4) immediately after intervention ends', 'description': 'Time to walk 10 metres'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation', 'Technology'], 'conditions': ['Stroke', 'Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The department (Biomedical Engineering, University of Strathclyde) co-creates rehabilitation technology. To improve the quality of the feedback the investigators have set up a programme of rehabilitation supervised by qualified therapists (physical therapists, occupational therapists and speech therapists) and delivered entirely through technology. This tests the feasibility of the overall approach as well as helping develop specific pieces of equipment.', 'detailedDescription': 'A key area of research activity within the Biomedical Engineering Dept. is the development of rehabilitation technologies to support the recovery of function in people with movement disorders such as stroke, cerebral palsy and spinal chord injury. A critical part of the design process for these technologies is the close involvement of users from concept through to prototype testing. Despite significant levels of investment rehabilitation technologies continue to experience barriers to adoption among private users and the health service with issues such as cost, usability, portability and accessibility cited as factors. Adopting a partnership approach towards the development of these technologies would address these issues.\n\nEngagement between technology designers and users is typically ad-hoc and project specific with users invited to attend design concept workshops or "try out" sessions with a technology in the prototype stages of its development. While these experiences are certainly useful they are unable to provide the in-depth information needed to inform the translation of these technologies into practice, neither do they provide the interactions capable of generating new ideas.\n\nThe aim of this project is to test the feasibility of a technology enriched rehabilitation programme in people living with stroke and gather user feedback on specific technology. The programme offers professionally supervised (therapists) access to an existing suite of commercially available and prototype rehabilitation technologies for 8 weeks, 2-5 times a week. Such an arrangement provides a critical source of feedback as well as creating considerable opportunity for new ideas to emerge, both for specific technologies and models of delivery. Specifically it would:\n\n1. Provide stroke survivors with time limited, professionally supervised, access to an integrated suite of rehabilitation technologies.\n2. Enable data to be collected from users on their response to the intervention. This would include:\n\n * Demographics (age, gender)\n * Stroke detail (number of strokes and time since last stroke).\n * Stroke related impairments in mobility, speech and cognition\n * Co-morbidities (number and nature).\n * Change in impairments as a response to the rehabilitation intervention\n3. Collect data on their interactions and general experiences with the rehabilitation technologies.\n\nThis would include a recorded interview at the end of their participation covering opinions on specific technologies and general views on the use of technology in the rehabilitation process including access. It will also conduct focus groups (n=5 to 8) to explore the use of goal setting and the development of an educational package to help individuals continue their rehabilitation after the programme completes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stroke at least 12 months previously\n* Currently well\n* Not currently receiving rehabilitation\n* Able to attend the programme for two hours at least twice a week\n* Able to follow instructions in English and follow provide verbal and/or written feedback\n\nExclusion Criteria:\n\n* Absolute contradictions to physical activity\n* Recent (6 weeks) deterioration in health\n* Change in medication\n* Currently unwell'}, 'identificationModule': {'nctId': 'NCT06787768', 'acronym': 'TERG', 'briefTitle': 'Technology Enriched Rehabilitation Gym', 'organization': {'class': 'OTHER', 'fullName': 'University of Strathclyde'}, 'officialTitle': 'User Experience of a Technology Based Rehabilitation Programme', 'orgStudyIdInfo': {'id': 'UStrathclyde_UEC20/08 Kerr'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic stroke survivors', 'description': 'People well enough to exercise lightly but living with motor impairment following a stroke at least 12 months previously', 'interventionNames': ['Other: Technology Enriched Rehabilitation Gym']}], 'interventions': [{'name': 'Technology Enriched Rehabilitation Gym', 'type': 'OTHER', 'description': 'The intervention is an 8-week long rehabilitation programme delivered entirely through technology, including virtual reality (immersed and non-immersed), treadmills, weight suspension and movement resistance, and power assistance equipment located in a gym-like space on a university campus. Individual programs are designed, supervised, and reviewed by a physiotherapist using principles of intensity, feedback, cognitive engagement, and aerobic activity to address the goals identified by the participant and scores from outcome measures at baseline. Participants attend a minimum of two times per week and can attend daily for the two hour group based circuit class.', 'armGroupLabels': ['Chronic stroke survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G44 3RL', 'city': 'Glasgow', 'state': 'Glasgow', 'country': 'United Kingdom', 'facility': 'University of Strathclyde', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Milena Sklachetka, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Strathclyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Strathclyde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}