Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-28 @ 1:34 AM
Study NCT ID:
NCT04281394
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2019-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients with full or virtually full thickness involvement of \\>50% on the body surface area of the lower extremity'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the changes of functional ambulatory category', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently. Higher scores mean a better outcome.'}, {'measure': 'the changes of 6 minutes walking test', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': '6MWT was performed in accordance with standardized guidelines, and the walking course was 20 m. Patients were instructed to walk as far as possible in 6 min. Higher scores mean a better outcome.'}, {'measure': 'the changes of visual analogue scale', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'Visual analogue scale was used to rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points. higher scores mean a worse outcome'}], 'secondaryOutcomes': [{'measure': 'the changes of active range of motion of flexion and extension', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(hip joint)'}, {'measure': 'the changes of active range of motion of flexion and extension', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(knee joint)'}, {'measure': 'the changes of active range of motion of dorsiflexion and plantarflexion', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'The active range of motion(ROM) of different joints was measured using a goniometer and an inclinometer with a standardized technique(ankle joint)'}, {'measure': 'the changes of isometric forces of knee flexion and knee extension', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'Isometric knee extension and knee flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded.'}, {'measure': 'the changes of isometric forces of ankle dorsiflexion and ankle plantarflexion', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'Isometric ankle dorsiflexion, and ankle plantar flexion muscle strength were measured by handheld dynamometer. Two measurements were taken using handheld dynamometer. Each trial lasted for 3-5 s, with 30 second rest period between trials. The higher of the two valid measurements was recorded.'}, {'measure': 'the changes of gait symmetry using stride length', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'Stride is the equivalent of a gait cycle. The duration of a stride is the interval between two sequential initial floor contacts by the same limb. symmetry ratio is defined with affected side stride length/ non affected side stride length.'}, {'measure': 'the changes of center of foot pressure pattern', 'timeFrame': 'baseline, and after 12 weeks intervention', 'description': 'center of foot pressure patten during a normal stride. longitudinal line analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burns', 'rehabilitation', 'robot assisted gait training'], 'conditions': ['Burns', 'Gait Disorder, Sensorimotor']}, 'referencesModule': {'references': [{'pmid': '27689789', 'type': 'BACKGROUND', 'citation': 'Goto K, Morishita T, Kamada S, Saita K, Fukuda H, Shiota E, Sankai Y, Inoue T. Feasibility of rehabilitation using the single-joint hybrid assistive limb to facilitate early recovery following total knee arthroplasty: A pilot study. Assist Technol. 2017 Winter;29(4):197-201. doi: 10.1080/10400435.2016.1219883. Epub 2016 Aug 10.'}, {'pmid': '30616685', 'type': 'RESULT', 'citation': "Kang MG, Yun SJ, Shin HI, Kim E, Lee HH, Oh BM, Seo HG. Effects of robot-assisted gait training in patients with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2019 Jan 7;20(1):15. doi: 10.1186/s13063-018-3123-4."}]}, 'descriptionModule': {'briefSummary': 'Gait enables individuals to move forward and is considered a natural skill. However, gait disturbances are very common in patients with burn injury. Major causes of functional impairment are pain and joint contractures. Recent studies focused on the application of robot-assisted gait training (RAGT). This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.', 'detailedDescription': 'This study aimed to elucidate the efficacy and investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.\n\n20 patients with burn were randomly divided into 2 groups. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. The conventional group underwent conventional physical therapy twice a day, 5 times a week in 12 weeks. Main outcomes were functional ambulatory category(FAC), 6 minutes walking test(6MWT), visual analogue scale(VAS), isometric forces of bilateral knee and ankle muscles, and foot pressure analysis before and after 12 weeks training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with full or virtually full thickness involvement of \\>50% on the body surface area of the lower extremity\n* age \\> 18 years\n* with ≤1 functional ambulation category (FAC) score ≤ 3\n\nExclusion Criteria:\n\n* patients with cognitive disorders before burn\n* serious cardiac dysfunction\n* problems with weight bearing due to unstable fractures\n* body weight ≥100 kg\n* severe fixed contracture\n* skin disorders that could be worsened by RAGT and conventional rehabilitation\n* patients with severe pain who were unable to undergo conventional rehabilitation programs.'}, 'identificationModule': {'nctId': 'NCT04281394', 'briefTitle': 'Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity', 'organization': {'class': 'OTHER', 'fullName': 'Hangang Sacred Heart Hospital'}, 'officialTitle': 'Effects of Robot-assisted Gait Training in Patients Burn Injury on Lower Extremity : a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HangangSHH-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot assisted gait training', 'description': 'Robot assisted gait training(RAGT) group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks. SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements.', 'interventionNames': ['Device: Robot assisted gait training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional physical training group', 'description': 'The conventional group underwent conventional physical therapy( even level gait training and range of motion exercises) twice a day, 5 times a week in 12 weeks.', 'interventionNames': ['Other: conventional gait training']}], 'interventions': [{'name': 'Robot assisted gait training', 'type': 'DEVICE', 'description': 'SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks.', 'armGroupLabels': ['Robot assisted gait training']}, {'name': 'conventional gait training', 'type': 'OTHER', 'description': 'even level gait training and range of motion exercises', 'armGroupLabels': ['conventional physical training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150-719', 'city': 'Seoul', 'state': 'Yeong-deungpo-Dong', 'country': 'South Korea', 'facility': 'Hangang Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangang Sacred Heart Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Republic of Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}