Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-01 @ 11:38 PM
Study NCT ID:
NCT07277166
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional ambulatory category', 'timeFrame': '12 weeks', 'description': 'Participants were rated on a six-point scale based on the level of physical assistance required for walking, regardless of whether an assistive device was used.'}], 'secondaryOutcomes': [{'measure': '6-Minute Walk Test (6MWT)', 'timeFrame': '12weeks', 'description': 'conducted according to standardized guidelines, on a 20-meter walking course. Patients were instructed to walk as far as possible in 6 min.'}, {'measure': 'visual analogue scale (VAS)', 'timeFrame': '12 weeks', 'description': 'rate the degree of subjective pain during gait movement (0 points : when no pain was noted, and 10 points : when unbearable pain was noted).'}, {'measure': 'sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases', 'timeFrame': '12 weeks', 'description': 'the total range of motion of hip, knee, and ankle during one gait cycle'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BURNS, Gait dysfunction, Wearable robot, Robot training'], 'conditions': ['Burns', 'Gait Dysfunction', 'Robot Training']}, 'referencesModule': {'references': [{'pmid': '39716173', 'type': 'RESULT', 'citation': "Shin JH, Byeon N, Yu H, Lee D, Lee HJ, Lee WH. Effect of wearable robot Bot Fit's hip joint-centered assist torque and voice coach on walking. BMC Musculoskelet Disord. 2024 Dec 23;25(1):1063. doi: 10.1186/s12891-024-08181-8."}, {'pmid': '40418849', 'type': 'RESULT', 'citation': 'Cho E, Hwang S, Heo SJ, Lim B, Lee J, Lee Y. Feasibility and Effects of a Gait Assistance and Gait Resistance Training Program Using a Walking-Assist Wearable Robot for Community-Dwelling Older Adults: Single-Group, Pre-, and Posttest Study. JMIR Mhealth Uhealth. 2025 May 26;13:e58142. doi: 10.2196/58142.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.', 'detailedDescription': "Regaining a mobility level post-surgery that comes close to the patient's previous mobility as a baseline is the goal. It is commonly accepted that conventional physiotherapy after burn injury has a positive impact on muscle strength, range of motion, pain or gait performance which all impact patient mobility. Wearable robots that assist walking centered on the hip joint of the lower extremities are appearing. This wearable robot is a positive effect in terms of increased energy efficiency and posture during walking. This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50%of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. This study excluded patients with fourth-degree burns (involving muscles, tendons, and bone injuries), severe communication disorders because of intellectual impairment and psychological problems. The specific exclusion criteria were as follows. Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more. Patients with heart and circulatory conditions that may affect gait training. Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. -aged over 18 years\n* had a Functional Ambulation Category (FAC) score of 3 or higher\n\nExclusion Criteria:\n\n* fourth-degree burns (involving muscles, tendons, and bone injuries)\n* severe communication disorders because of intellectual impairment and psychological problems\n* Patients with body types that prevent them form wearing the robot, such as a height of 4.59 feet (140cm) or 5.91 feet (185cm) or more, or severe obesity with a BMI of 35 or more.\n* Patients with heart and circulatory conditions that may affect gait training.\n* Patients at a high risk of falling during gait training, owing to severe dizziness and having experienced a fall within the preceeding 2 month.'}, 'identificationModule': {'nctId': 'NCT07277166', 'briefTitle': 'The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury', 'organization': {'class': 'OTHER', 'fullName': 'Hangang Sacred Heart Hospital'}, 'officialTitle': 'The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury : Pilot Study', 'orgStudyIdInfo': {'id': 'HangangSHH-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearable robot training', 'description': 'The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks.', 'interventionNames': ['Other: wearable robot training']}], 'interventions': [{'name': 'wearable robot training', 'type': 'OTHER', 'description': 'The wearable robot (WIRobotics Inc) is a wearable robot designed to provide assistive torque and resistive torque for hip movement. It is worn around the waist and thighs and weight approximately 1.6 kg. The main body and actuation parts are not located at the hip joints and back to avoid restricting body movements and to facilitate movement even in cramped spaces. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks.', 'armGroupLabels': ['Wearable robot training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07247', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ragyem Sung', 'role': 'CONTACT', 'email': 'sung6652@hallym.or.kr', 'phone': '82-10-5939-2541'}], 'facility': 'Hangang sacred heart hodpital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'SO YOUNG JOO', 'role': 'CONTACT', 'email': 'anyany98@gmail.com', 'phone': '82-10-3234-9839'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangang Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of rehabilitation medicine of Hangang Sacred heart hospial', 'investigatorFullName': 'So Young Joo', 'investigatorAffiliation': 'Hangang Sacred Heart Hospital'}}}}