Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT06560450
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research Report: CERITER Clinical Study - Stride One
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-11', 'size': 291806, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-08T09:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Ten patients were offered therapy using Stride One for one week. Several measurements are performed before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete and correct foot roll-off', 'timeFrame': '1 week while daily therapy was given', 'description': 'The first primary endpoint of the study is the complete and correct foot roll-off (detected and interpreted in the Ceriter platform). Stride One provides auditory feedback to the patient, stimulating the patient to achieve a good roll-off of the foot. For each step it measures whether a correct heel-strike, mid-stance and terminal stance are achieved. The aim of Stride One is to teach patients to place their feet correctly, in order to obtain a better roll- off, using positive audio feedback.'}, {'measure': 'Changed walking speed/greater number of steps per minute', 'timeFrame': '1 week while daily therapy was given'}], 'secondaryOutcomes': [{'measure': 'Improved functional tests: 5x sit-to-stand (seconds)', 'timeFrame': 'Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy', 'description': '• 3-minute walking test with audio feedback (distance in meter + roll-off pattern and Recording of auditory feedback via CERITER software), only at T1 and T2'}, {'measure': 'Improved functional tests: 3-minute walking test without audio feedback', 'timeFrame': 'Before the start of the therapy, immediately after the end of the intervention period and 2 days after the end of the therapy', 'description': 'Distance in meter + roll-off pattern via CERITER software'}, {'measure': 'Improved functional tests: 3-minute walking test with audio feedback', 'timeFrame': 'Before the start of the therapy and immediately after the end of the intervention period', 'description': 'Distance in meter + roll-off pattern and recording of auditory feedback via CERITER software'}, {'measure': 'Subjective experiences: questionnaires', 'timeFrame': 'Post intervention, 2 days after end of the therapy', 'description': 'Immediately after the end of the intervention week, the patient and the treating therapist were asked about their findings regarding the use of Stride One while walking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CVA (Cerebrovascular Accident)', 'Gait rehabilitation', 'Gait analysis', 'Tele-rehabilitation'], 'conditions': ['CVA (Cerebrovascular Accident)']}, 'referencesModule': {'references': [{'pmid': '30603178', 'type': 'BACKGROUND', 'citation': 'Khoo IH, Marayong P, Krishnan V, Balagtas M, Rojas O, Leyba K. Real-time biofeedback device for gait rehabilitation of post-stroke patients. Biomed Eng Lett. 2017 Jun 7;7(4):287-298. doi: 10.1007/s13534-017-0036-1. eCollection 2017 Nov.'}, {'pmid': '37548025', 'type': 'BACKGROUND', 'citation': 'Kwakkel G, Stinear C, Essers B, Munoz-Novoa M, Branscheidt M, Cabanas-Valdes R, Lakicevic S, Lampropoulou S, Luft AR, Marque P, Moore SA, Solomon JM, Swinnen E, Turolla A, Alt Murphy M, Verheyden G. Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. Eur Stroke J. 2023 Dec;8(4):880-894. doi: 10.1177/23969873231191304. Epub 2023 Aug 7.'}, {'pmid': '34827376', 'type': 'BACKGROUND', 'citation': 'Kim J, Jung S, Song C. The Effects of Auditory Feedback Gait Training Using Smart Insole on Stroke Patients. Brain Sci. 2021 Oct 21;11(11):1377. doi: 10.3390/brainsci11111377.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to investigate the short-term impact of the use of Ceriter Stride One on the quality of gait in patients rehabilitating after a cerebrovascular accident (CVA). Stride One is a smart insole that provides real-time audio feedback (cues) to the patient when performing a certain exercise.\n\nThe main questions it aims to answer are:\n\n* Will patients with a CVA show a qualitatively better gait pattern after training with a Stride One insole?\n* Can patients maintain this improvement in gait pattern without audio feedback at the end of the training?\n\nParticipants will\n\n* Receive daily gait rehabilitation using Stride One for 1 week\n* The quality of the gait pattern was evaluated at the beginning and at the end of the week, with and without the use of Stride One\n* An additional evaluation was performed three to four days after the end of therapy without the use of Stride One\n* Immediately after the end of the intervention week, the patient and the treating therapist were asked about their findings regarding the use of Stride One while walking', 'detailedDescription': 'Both therapist and patient reported an improvement in the quality of the foot roll-off pattern in 100% of cases. This improvement was also objectively determined in the data measured by Stride One, with an average of 8% improvement on Stride One general quality parameter, and an average of 25% improvement on Stride One specific quality parameter for the specific patient. Furthermore, 89% of patients indicate that using Stride One helps them to understand their physiotherapist better, and 67% of patients indicate that they can practice more and better with Stride One.\n\nPracticing one week with Stride One generates a positive clinical impact on the gait pattern. A lasting improvement in the gait pattern without using Stride One, three to four days after the intervention, could not be demonstrated in this short time period. Further research is needed to evaluate the effect of Stride One after more long-term use.\n\nAdditional research questions are suggested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CVA, residentially admitted to the rehabilitation center in Herk-de-Stad, Belgium\n* Older than 18 years of age\n* Gait problems as a result of the CVA\n* Able to walk safely and independently (possibly with a walking aid)\n* Able to understand and sign an information and consent form\n\nExclusion Criteria:\n\n* Severe cognitive problems (attention) that make it difficult to understand instructions or follow feedback\n* Hearing problem'}, 'identificationModule': {'nctId': 'NCT06560450', 'briefTitle': 'Research Report: CERITER Clinical Study - Stride One', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ceriter Nederland BV'}, 'officialTitle': 'Research Report: CERITER Clinical Study - Stride One', 'orgStudyIdInfo': {'id': 'CVA-STRIDE-1-FRAME01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Real-time audio feedback', 'description': 'Physiotherapist-defined real-time audio feedback', 'interventionNames': ['Device: Stride One']}], 'interventions': [{'name': 'Stride One', 'type': 'DEVICE', 'description': 'Stride One is a smart insole that provides real-time audio feedback (cues) to the patient when performing a certain exercise. The goal of Stride One is to allow patients to practice walking more intensively and with higher quality during rehabilitation.', 'armGroupLabels': ['Real-time audio feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Frame, Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Sarah Meyer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Frame Jessa Ziekenhuis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ceriter Nederland BV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'FRAME Jessa Ziekenhuis, Belgium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}