Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:08 AM
Study NCT ID:
NCT07445035
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'manual muscle testing', 'timeFrame': '2 weeks', 'description': '0 indicates no detectable muscle contraction, and 5 represents normal muscle strength.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prolonged mechanical ventilation', 'ventilator weaning', 'lower limb muscle strengthening', 'exoskeleton robot', 'exercise training'], 'conditions': ['Prolonged Mechanical Ventilation', 'Ventilator Weaning', 'Ventilator Dependent', 'Exoskeleton Device', 'Exercise Training']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of powered lower-limb exoskeleton-assisted training on lower limb strength, respiratory parameters, 28-day ventilator-free days, and length of hospital stay in patients with prolonged mechanical ventilation admitted to a Respiratory Care Center. The goal is to provide clinical evidence for integrating rehabilitation and respiratory care in this patient population.', 'detailedDescription': 'Background:\n\nPatients with prolonged mechanical ventilation often experience lower limb muscle weakness, respiratory muscle dysfunction, and impaired functional status due to prolonged bed rest, leading to lower weaning success rates and extended hospital stays. In recent years, exoskeleton robots have emerged as assistive training tools and have demonstrated potential in improving lower limb function and cardiopulmonary endurance in neurological and orthopedic populations. However, evidence supporting their use in prolonged mechanical ventilation patients remains limited.\n\nStudy Design： This study will be conducted in the Respiratory Care Center of Fu Jen Catholic University Hospital using purposive sampling.\n\nMethods:\n\nA total of 30 prolonged mechanical ventilation patients will be recruited and matched in a 1:1 ratio based on gender, age, and intensive care unit length of stay. The intervention group will receive exoskeleton-assisted training, while the control group will receive standard care without the intervention. Recruitment and informed consent will be conducted by research staff unaffiliated with the Respiratory Care Center.\n\nEffect:\n\nThe study is expected to identify differences between the exoskeleton intervention and control groups in terms of lower limb muscle strength, respiratory physiological parameters, 28-day ventilator-free days, and hospital length of stay. The results will provide scientific evidence and practical guidance for the clinical integration of exercise rehabilitation and respiratory care for prolonged mechanical ventilation patients.\n\nKey words:\n\nProlonged Mechanical Ventilation, Exoskeleton Robot, Exercise Training, Lower Limb Muscle Strengthening, Ventilator Weaning'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to maintain a seated position for at least 1 minute.\n* The participant or their legal representative is able to sign the informed consent form.\n\nExclusion Criteria:\n\n* Inability to follow instructions.\n* Intubation/tracheostomy prior to current admission.\n* Diagnosis of severe left heart failure.\n* Diagnosis of neuromuscular disorders.\n* Unable to stand.\n* Complete paralysis of the lower extremities.\n* Presence of unhealed ulcers in the lower extremities.\n* Deep vein thrombosis of the lower extremities.\n* Lower-limb amputation.\n* Severe hypertension\n* Severe cardiac conditions\n* Severe bilateral joint disorders\n* Severe pain while standing\n* Severe osteoporosis\n* Lower-limb fracture\n* Ongoing epileptic seizure'}, 'identificationModule': {'nctId': 'NCT07445035', 'briefTitle': 'Effects of Mobilization Using a Powered Lower-limb Exoskeleton With Prolonged Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Physiological and Functional Adaptations Associated With Robot-assisted Lower-limb Activity in Ventilator-dependent Hospitalized Patients', 'orgStudyIdInfo': {'id': 'FJUH114479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard care group', 'description': 'receive standard care without the intervention', 'interventionNames': ['Other: Standard medical treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Powered lower-limb exoskeleton group', 'description': 'receive standard care with exoskeleton-assisted training', 'interventionNames': ['Device: lower-limb exoskeleton']}], 'interventions': [{'name': 'lower-limb exoskeleton', 'type': 'DEVICE', 'description': 'regular therapy plus exoskeleton training', 'armGroupLabels': ['Powered lower-limb exoskeleton group']}, {'name': 'Standard medical treatment', 'type': 'OTHER', 'description': 'regular therapy', 'armGroupLabels': ['standard care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.con', 'phone': '+886905301879'}], 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'C00152@mail.fjuh.fju.edu.tw', 'phone': '+886-905-301-879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}