Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03493633
Status:
TERMINATED
Last Update Posted:
2023-03-21
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use EzyGain at Home (Device for Walking at Home)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'targetDuration': '9 Weeks', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'early termination - fault of inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of sessions performed on the device during the duration of the study', 'timeFrame': 'Up to 4 weeks', 'description': 'Count of the number of sessions performed. A session is considered to be performed when the patient is walking for at least one minute on the EzyGain treadmill with the APA investigator / caregiver.'}], 'secondaryOutcomes': [{'measure': 'Number of sessions performed autonomously by the caregiver', 'timeFrame': 'Up to 4 weeks', 'description': 'Measure of the number of self-help sessions performed by the caregiver and their proportion to the total number of sessions completed.'}, {'measure': 'Physical activity evaluate by actimetry before the training period', 'timeFrame': 'At days 7 before the training period', 'description': 'Evaluate spontaneous physical activity by actimetry over a continuous period of 7 days before the beginning of the exercise period.\n\nAt day #1 of the 7-day period : put the Actigraph© on the patient At day #7 of the 7-day period : take the Actigraph© off the patient'}, {'measure': 'Physical activity evaluate by QAPPA before the training period', 'timeFrame': 'At days 7 before the training period', 'description': 'Evaluate spontaneous physical activity by QAPPA, 7 days before the beginning of the exercise period.\n\nAt day #7 of the 7-day period do the QAPPA'}, {'measure': 'Physical activity evaluate by actimetry just after the training period', 'timeFrame': 'At days 7 after the end of the training period', 'description': 'Evaluate spontaneous physical activity by actimetry over a continuous period of 7 days starting the day after the end of the exercise period.\n\nAt day #1 of the 7-day period : put the Actigraph© on the patient At day #7 of the 7-day period : take the Actigraph© off the patient'}, {'measure': 'Physical activity evaluate by QAPPA just after the training period', 'timeFrame': 'At days 7 after the end of the training period', 'description': 'Evaluate spontaneous physical activity by QAPPA over period of 7 days starting the day after the end of the exercise period.\n\nAt day #7 of the 7-day period do the QAPPA'}, {'measure': 'Physical activity evaluate by actimetry 3 weeks after the training period', 'timeFrame': 'At 3 weeks after the training period', 'description': 'Evaluate spontaneous physical activity by actimetry over a continuous period of 7 days starting 3 weeks after the end of the exercise period.\n\nAt day #1 of the 7-day period : put the Actigraph© on the patient At day #7 of the 7-day period : take the Actigraph© off the patient'}, {'measure': 'Physical activity evaluate by QAPPA 3 weeks after the training period', 'timeFrame': 'At 3 weeks after the training period', 'description': 'Evaluate spontaneous physical activity by QAPPA over a continuous period of 7 days starting 3 weeks after the end of the exercise period.\n\nAt day #7 of the 7-day period do QAPPA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Disability', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the training work of walking in everyday life compared to a conventional care.', 'detailedDescription': "Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the work of training of walking in everyday life compared to a conventional care. In addition, we believe that this practice should be supervised by a caregiver trained by the physiotherapist / APA investigator, in order to increase the use of the device.\n\nThe people concerned by this protocol are those who have a partial disability of walking whatever the pathology and the underlying deficiencies.\n\nMain objective: To evaluate the feasibility of using EzyGain at home.\n\nMain Evaluation Criteria: Number of sessions performed on the device during the duration of the study, compared to the number of scheduled sessions.\n\nSecondary objectives\n\nSecondary objective 1: make a partial transfer of the supervision of the physiotherapist / APA investigator's sessions to the caregiver.\n\nSecondary Objective 2: To evaluate whether the exercise period on the device increases the amount of spontaneous physical activity of the patient after the end of the period compared to the average spontaneous physical activity prior to the exercise period.\n\nPopulation concerned:\n\nPopulation over 60 years of age with partial walking disability regardless of etiology and pathology leading to walking disability.\n\nPopulation coming into consultation in the services of Dr. Teixeira and Pr. Yelnik of GH Saint Louis Lariboisière Fernand Widal.\n\nPartial incapacity of walking. Availability at home during their participation period (weeks of walking exercise + weeks of evaluation of physical activity).\n\nEthnicity indifferent Indifferent sex Patient with a close volunteer caregiver to participate in the study and receive training from the investigator / APA investigator and then manage sessions autonomously.\n\nAnyone who would like to train more regularly on the walk and at home because unable to go out.\n\nWho uses or does not use technical assistance to walk or move Patient who falls or is at risk of falling and, as a result, limits his progress.\n\nPossibility of installation of the device in the patient's home. Patient affiliated to a social security scheme\n\nPractical sequence:\n\nSelection and medical inclusion of the patient by one of the investigating physicians and delivery of consent. During this visit, the doctor judges the eligibility criteria, explains the research to the patient, gives him the informed consent that is signed on the spot.\n\nAmong the eligibility criteria, there must be a caregiver close to the patient, who is willing to participate in the research. If he is present during this visit, he signs his consent to participate in the research. If he is absent during this visit, the patient gives his coordinates, the doctor calls him to explain the research, and sends his consent by mail, which the caregiver returns signed by mail to the doctor. It only remains to verify that the apartment can accommodate the device EzyGain.\n\nEvaluation of the accessibility of the home by the EzyGain team. If the apartment can accommodate the device, then the patient is included in the search. If the apartment can not accommodate the device, then the patient is not included.\n\nThe first visit takes place on site with the investigator / APA investigator and an investigator. Laying the Actigraph ©.\n\nEvaluation of the spontaneous physical activity of the patient by actimetry for seven days + QAPPA (questionnaire of physical activity for old person).\n\nBeginning of the training phase on the device. The dosage of the activity (frequency of sessions and practical content) and the possibility of supervising additional sessions by a family caregiver is determined by the investigating physiotherapist / APA investigator.\n\nEach patient performs a minimum of 3 sessions per week with the investigator / APA investigator, for 4 weeks, each walk for a few minutes (\\<60 min).\n\nEvaluation of the spontaneous physical activity of the patient by actimetry for seven days QAPPA (questionnaire of physical activity for elderly person) a week and a month after the training phase of four weeks"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population over 60 years of age with partial walking disability regardless of etiology and pathology leading to walking disability.\n\nPopulation coming into consultation in the services of Dr. Teixeira and Pr. Yelnik of GH Saint Louis Lariboisière Fernand Widal.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Person over the age of 60\n* Availability at home during their participation period (walking exercise weeks + physical activity assessment weeks).\n* Patient with a volunteer close caregiver to participate in the study and receive training from the investigator/APA investigator and then manage autonomy sessions.\n* Person who would like to train more regularly in the walk and at home because unable to get out. Person who uses or does not use technical assistance to walk or move\n* Person in a State to sign informed consent alone\n* Possibility of installation of the device in the patient's home (the dimensions of the lift/doors/parts allow the device to be entered in the apartment, as well as not to hinder the daily life of the patient too heavily).\n* Patient affiliated with a Social security plan\n* Person who has a partial limitation of walking activity (partial inability to walk) and in whom, re-education of walking is relevant to improve performance (whether or not the patient does this re-education at the time of the visit of selection). The criteria for limiting walking activity are:\n* Speed limitation\n* Endurance limitation\n* Limitation of the operating perimeter\n* Limitation of the dynamic balancing during walking failure to position the foot or feet during walking\n* Falls\n* Availability at home during their time of participation.\n* Indifferent ethnic origin\n* Indifferent sex\n\nExclusion Criteria:\n\n* Uncontrolled heart failure\n* Uncontrolled respiratory insufficiency\n* Uncontrolled coronary insufficiency\n* Impossibility of installing the device at home\n* Severe cognitive impairment with risk of using the device alone, outside of the instructions\n* Absence of a caregiver to follow a continuous training of the physiotherapist / - APA investigator to supervise independently one or two sessions per week"}, 'identificationModule': {'nctId': 'NCT03493633', 'acronym': 'EzyGain', 'briefTitle': 'Use EzyGain at Home (Device for Walking at Home)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home', 'orgStudyIdInfo': {'id': 'P170705J'}, 'secondaryIdInfos': [{'id': '2017-A03170-53', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'EzyGain at Home', 'description': 'Setting up a walking device at home for people aged 60 years with partial walking disability regardless of etiology and pathology leading to walking disability.', 'interventionNames': ['Device: EzyGain']}], 'interventions': [{'name': 'EzyGain', 'type': 'DEVICE', 'description': 'Each patient performs a minimum of 3 sessions per week with the investigator / APA investigator, for 4 weeks, each walk for a few minutes (\\<60 min).\n\nEvaluation of the spontaneous physical activity of the patient by actimetry for seven days QAPPA (questionnaire of physical activity for elderly person) a week and a month after the training phase of four weeks', 'armGroupLabels': ['EzyGain at Home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Médecine Physique et de Réadaptation - Hôpital F.Widal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alain YELNIK', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}