Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT06948695
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-02-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063996', 'term': 'Warm-Up Exercise'}], 'ancestors': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'prospective randomized cross-over study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen consumption measurement', 'timeFrame': 'Day 1', 'description': '4-minute flat run on a treadmill at comfort speed'}], 'secondaryOutcomes': [{'measure': 'Oxygen consumption measurement', 'timeFrame': 'Day 1', 'description': '4-minute up hill run (+10%), on a treadmill at comfort speed'}, {'measure': 'Kinematic analysis', 'timeFrame': 'Day 1', 'description': 'Slope-dependent kinematic analysis by measuring joint angles (in degrees), moments (Nm) and net joint forces at ankle, knee and hip (in Nm/Kg), ground reaction forces (in N/Kg) during a 1-minute run on different slopes (downhill -10%, flat, uphill +10%).'}, {'measure': 'Cadence of running (in steps per minutes)', 'timeFrame': 'Day 1', 'description': 'Cadence of running according to slope (downhill -10%, flat, uphill +10%) and terrain, measured during a 1-minute run on a carpet'}, {'measure': 'Stride length (in meters) of running', 'timeFrame': 'Day 1', 'description': 'Stride length of running according to slope (downhill -10%, flat, uphill +10%) and terrain, measured during a 1-minute run on a carpet'}, {'measure': 'Cadence (in steps per minute) of running', 'timeFrame': 'Day 2', 'description': 'Cadence of running according to gradient (downhill -10%, flat, uphill +10%) and type of terrain, measured during a 100-metre run on roads and paths.'}, {'measure': 'Stride length (in metres) of running', 'timeFrame': 'Day 2', 'description': 'Stride length (in metres)of running according to gradient (downhill -10%, flat, uphill +10%) and type of terrain, measured during a 100-metre run on roads and paths.'}, {'measure': 'Leg muscle activity (mV)', 'timeFrame': 'Day 1, 2', 'description': 'Recording of leg muscle activity under all conditions using surface electromyographic recordings (Trigno wireless electromyogram (EMG) electrodes (Delsys, Natick, USA) made on the vastus lateralis, rectus femoris and gluteus medius muscles (Root Mean Square (RMS).'}, {'measure': 'Subjective sensation recording', 'timeFrame': 'Day 1, 2', 'description': 'Recording of the subjective sensation of perceived exertion at the end of each condition using a Borg scale ranging from 0 to 10.\n\n0 = It is very very easy 10= so hard that I have to stop'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unilateral transtibial amputees', 'Endurance runners'], 'conditions': ['Amputee', 'Prostheses', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': "Transtibial amputation accounts for 3,700 cases per year in France. Athletes can use sport blades made of carbon plate for improved energy restitution.\n\nSports blades are adjusted according to the manufacturer's recommendations and the subjective experience of the ortho-prosthetist and patient. These adjustments are designed to optimize performance and comfort while reducing the risk of injury. This risk is all the greater when asymmetries between the healthy and affected limbs are large, exposing the healthy limb to large and repeated reaction forces.", 'detailedDescription': 'Furthermore, one of the performance criteria for long-distance running is energy cost. While a reduction in this parameter has been observed in bilateral amputees, heterogeneous data are reported in unilateral amputees, depending on the level of expertise and sports blade settings.\n\nWhile studies have investigated the effects of running with a prosthesis under conditions representative of track running, few data are available on sports blades designed for long-distance running.\n\nIt therefore seems important to be able to objectively assess the effects of a change in the stiffness of the sports blade on the energetics and biomechanics of running, in order to optimize practice and prevent associated traumas.\n\nSecondly, investigators believe it is important to verify that the biomechanical results obtained in the laboratory are applicable in the field, both on the road and on the unstable terrain encountered by trail runners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female,\n* Weighing less than 110 kg, in accordance with C-blade recommendations,\n* Subjects who have undergone a unilateral transtibial amputation,\n* Have been running with a sports blade for at least 3 months, over several sessions of at least 3 kilometers.\n* Subjects who have signed a written consent form,\n* Subjects affiliated or entitled to a social security scheme.\n\nExclusion Criteria:\n\n* Subjects whose amputation is due to complications related to diabetes or atherosclerosis.\n* Subjects with chronic or central neurological pathologies\n* Subjects with cardiovascular disorders\n* Subjects with alcohol or drug dependency.\n* Pregnant or breast-feeding women\n* Subjects under court protection.'}, 'identificationModule': {'nctId': 'NCT06948695', 'acronym': 'BLADENDURUN', 'briefTitle': 'Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees According to the Stiffness of the Race-specific Prothesis.', 'orgStudyIdInfo': {'id': '24CH148'}, 'secondaryIdInfos': [{'id': '2024-A01795-42', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual blade stiffness', 'description': 'Data collection on a blade with usual stiffness during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).', 'interventionNames': ['Other: Warm-up', 'Other: Random blade test', 'Other: Comfort speed test', 'Other: Outdoor random blade test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Less stiff blade', 'description': 'Data collection on a less stiff blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).', 'interventionNames': ['Other: Warm-up', 'Other: Random blade test', 'Other: Comfort speed test', 'Other: Outdoor random blade test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stiffer blade', 'description': 'Data collection on a stiffer blade during a run at comfort speed according to slope (flat, uphill +10% and downhill -10% on treadmill) and type of terrain (road, path).', 'interventionNames': ['Other: Warm-up', 'Other: Random blade test', 'Other: Comfort speed test', 'Other: Outdoor random blade test']}], 'interventions': [{'name': 'Warm-up', 'type': 'OTHER', 'description': '5-minute warm-up run on treadmill at a freely chosen speed', 'armGroupLabels': ['Less stiff blade', 'Stiffer blade', 'Usual blade stiffness']}, {'name': 'Random blade test', 'type': 'OTHER', 'description': '4-minute run on a treadmill with a flat incline.', 'armGroupLabels': ['Less stiff blade', 'Stiffer blade', 'Usual blade stiffness']}, {'name': 'Random blade test', 'type': 'OTHER', 'description': '4-minute run on treadmill with a 10% gradient', 'armGroupLabels': ['Less stiff blade', 'Stiffer blade', 'Usual blade stiffness']}, {'name': 'Comfort speed test', 'type': 'OTHER', 'description': '1 min running test on an instrumented treadmill (Gaitway, H/P/Cosmos, Nußdorf, Germany) at comfort speed.', 'armGroupLabels': ['Less stiff blade', 'Stiffer blade', 'Usual blade stiffness']}, {'name': 'Outdoor random blade test', 'type': 'OTHER', 'description': '100-metre outdoor run at a comfort speed', 'armGroupLabels': ['Less stiff blade', 'Stiffer blade', 'Usual blade stiffness']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David HUPIN, MD-PhD', 'role': 'CONTACT', 'email': 'david.hupin@chu-st-etienne.fr', 'phone': '(0)4 77 82 83 00', 'phoneExt': '+33'}, {'name': 'David HUPIN, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'David HUPIN, MD-PhD', 'role': 'CONTACT', 'email': 'david.hupin@chu-st-etienne.fr', 'phone': '(0)4 77 82 83 00', 'phoneExt': '+33'}, {'name': 'Léonard FEASSON, MD-PhD', 'role': 'CONTACT', 'email': 'leonard.leasson@chu-st-etienne.fr', 'phone': '(0)4 77 82 83 00', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'David HUPIN, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}