Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT03530956
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Bionic Foot, AMPfoot 4+
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking distance of a 6 minute walk test', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Distance walked during a 6 minute hallway walk test'}, {'measure': 'Walking speed of a 6 minute walk test', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Walking speed during a 6 minute walk test'}, {'measure': 'Walking speed of a 10 meter walk test', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Walking speed during a 10 meter walk test'}, {'measure': 'Duration of backward counting during walking (dual task)', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Duration of the cognitive task backward counting'}, {'measure': 'Accuracy of backward counting during walking (dual task)', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Accuracy of responses of the cognitive task'}, {'measure': 'Heart rate during walking tasks', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Heart rate during 6 minute and 10m walk tests'}, {'measure': 'Rating of Perceived Exertion during walking tasks', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Rating of Perceived Exertion ranges from 6 (no exertion) until 20 (maximal exertion) during 6 minute and 10m walk tests. Higher values indicate a higher subjective feeling of exertion.'}, {'measure': 'Oxygen consumption (VO2) during 6 minute walk test', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'VO2 during 6 minute walk test'}, {'measure': 'Visual analogue scale for fatigue during 6 min walk test', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Value at a scale (from 1 to 10) is provided using an X (as sign) and determines level of fatigue during walking. The higher the value the higher the level of fatigue'}, {'measure': 'Visual analogue scale for comfort during 6 min walk test', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Value at a scale (from 1 to 10) is provided using an X (as sign) and determines level of comfort during walking. The higher the value the higher the level of comfort.'}, {'measure': 'Brain activity', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Non-invasive electro-encephalography during walking'}, {'measure': 'Muscle activity', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Non-invasive electro-myography during walking'}, {'measure': 'Heart activity', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Non-invasive electro-cardiography during walking'}, {'measure': 'Electrodermal activity', 'timeFrame': 'Through study completion, a period of 8 months', 'description': 'Skin sensor during walking determines level of arousal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AMPfoot', 'dual-task', 'cognitive performance', 'physical performance', 'lower-limb prosthesis'], 'conditions': ['Prosthesis User', 'Cognitive Change', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Background: Evaluating the use of a novel motorized ankle prosthesis during walking and under dual task circumstances is an important step in product development.\n\nObjective: To iteratively evaluate the effectiveness of a novel bionic foot, the Ankle Mimicking Prosthetic device 4+ (or AMPfoot 4+), during walking.\n\nStudy design: Case study (crossover) research design.\n\nMethods: One male subject will conduct a baseline experimental trial with the current prosthetic device and several experimental trials with the AMPfoot 4+ to evaluate the effectiveness of the novel device and investigate the adaptation period. Prior to baseline experiments, a familiarization trial will be performed to determine intra-subject variability of the dual task. An experimental trial consists of 2 walking tasks, i.e. the 6-minute walk test (6MWT) and the 10-meter walk test. The 6MWT will be combined with a cognitive task, i.e. backwards counting, to create dual task circumstances. The outcome measurements for the dual task are the distance covered and the walking speed, heart rate (HR) (Polar), rating of perceived exertion (RPE), VO2 (Cosmed K5), electro-encephalography (EEG), electro-myography (EMG), electro-cardiography (ECG), electrodermal activity (/skin conductance),accuracy and total duration of the cognitive task, BodyMedia (physical activity) and the visual analogue scale (VAS) for fatigue and comfort. A 10-meter walk test will be evaluated on duration.\n\nExpected findings: In a first phase the novel device will probably reduce walking and cognitive performance, whereas fine-tuning the mechatronics (after several retests) should improve walking and cognitive performance during walking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral transtibial (below knee) amputee\n* healthy subject\n* K4-level (Medicare), which means highest ambulation level\n\nExclusion Criteria:\n\n* comorbidities\n* pain in stump'}, 'identificationModule': {'nctId': 'NCT03530956', 'briefTitle': 'Evaluation of a Novel Bionic Foot, AMPfoot 4+', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+', 'orgStudyIdInfo': {'id': 'SRP 17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Current prosthesis', 'description': 'A unilateral transtibial amputee will conduct experiments with the current prosthesis', 'interventionNames': ['Device: Ankle Mimicking Prosthetic Foot prototype 4+']}, {'type': 'EXPERIMENTAL', 'label': 'Novel prosthesis', 'description': 'A unilateral transtibial amputee will conduct experiments with the novel prosthesis', 'interventionNames': ['Device: Ankle Mimicking Prosthetic Foot prototype 4+']}], 'interventions': [{'name': 'Ankle Mimicking Prosthetic Foot prototype 4+', 'type': 'DEVICE', 'description': 'The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)', 'armGroupLabels': ['Current prosthesis', 'Novel prosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Brussels', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'Vrije Universiteit Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Philosophy', 'investigatorFullName': 'Kevin De Pauw', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}