Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:43 PM
Study NCT ID:
NCT07492732
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2025-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Selected Training Methods and SIS Stimulation on Balance, Motor Tests, and Strength
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medial-Lateral Stability Index (MLSI)', 'timeFrame': 'Baseline and immediately post-intervention (Week 4)', 'description': 'Assessment of medial-lateral postural stability using a balance platform'}, {'measure': 'Overall Stability Index (OSI)', 'timeFrame': 'Baseline and immediately post-intervention (Week 4)', 'description': 'Assessment of overall postural stability using a balance platform'}, {'measure': 'Anteroposterior Stability Index (APSI)', 'timeFrame': 'Baseline and immediately post-intervention (Week 4)', 'description': 'Assessment of anteroposterior postural stability using a balance platform'}, {'measure': 'Maximal hamstring muscle strength', 'timeFrame': 'Baseline and immediately post-intervention (Week 4)', 'description': 'Maximal voluntary strength of the hamstring muscles will be assessed bilaterally using a standardized strength testing protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plyometric', 'neuromuscular'], 'conditions': ['Hamstring Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of four-week training interventions-Nordic Hamstring Exercise, plyometric training, and neuromuscular training-combined with Super Inductive Stimulation (SIS) on hamstring muscle strength, balance, and motor performance.', 'detailedDescription': 'This randomized controlled study evaluates the effects of three four-week training interventions-Nordic Hamstring Exercise, plyometric training, and neuromuscular training-performed alone or in combination with Super Inductive Stimulation (SIS) in physically active adults.\n\nThe study is conducted in three independent stages, each corresponding to a specific training modality. Within each stage, participants are randomly allocated to one of four parallel groups: (1) training combined with SIS, (2) training only, (3) SIS only, or (4) control (no change in habitual physical activity). This design enables assessment of both isolated and combined effects of exercise and electromagnetic stimulation.\n\nAll interventions are delivered over a four-week period under supervision. Training protocols are standardized and specific to the intervention type, targeting eccentric strength (Nordic Hamstring Exercise), explosive performance (plyometric training), or neuromuscular control (neuromuscular training).\n\nSIS is applied to the hamstring muscle group using a high-intensity electromagnetic stimulation device, with standardized parameters across participants.\n\nA familiarization phase is conducted prior to the intervention to ensure consistency in procedures. Adherence and protocol compliance are monitored throughout the study.\n\nThis study aims to determine the relative and combined effectiveness of these interventions in improving neuromuscular performance in physically active individuals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Physically active individuals aged 19-40 years, performing a minimum of two training sessions per week.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy individuals aged 19-40,\n* Without injuries,\n* Physically active persons, athletes.\n\nExclusion Criteria:\n\n* periods of peak training load specific to the athlete's discipline,\n* evidence of overload-related pathology in the knee, hip, or lumbosacral joints,\n* the presence of any pain symptoms,\n* clinically relevant muscle fatigue or indicators of overtraining,\n* engagement in strength-based sports within several weeks preceding competition,\n* active inflammatory conditions involving osseous, articular, or ligamentous structures of the lower limbs,\n* a history of injury or surgical intervention within the 6 months prior to the study intervention."}, 'identificationModule': {'nctId': 'NCT07492732', 'briefTitle': 'Comparison of the Effects of Selected Training Methods and SIS Stimulation on Balance, Motor Tests, and Strength', 'organization': {'class': 'OTHER', 'fullName': 'Gdansk University of Physical Education and Sport'}, 'officialTitle': 'Comparison of the Effects of Selected Training Methods (Neuromuscular Training, Plyometric Training, and Nordic Hamstring Exercise) and SIS Stimulation on Balance, Motor Performance Tests, and Lower Limb Strength', 'orgStudyIdInfo': {'id': 'AWFiS/2025_9_EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nordic Hamstring Exercises + SIS stimulation', 'description': 'The participants will be randomly assigned to four research groups. The first research group will undergo a four-week Nordic Hamstring Exercise training program combined with Super Inductive Stimulation applied to the hamstring muscle group. The second research group will perform a four-week Nordic Hamstring Exercise training program. The third research group will undergo a four-week series of Super Inductive Stimulation sessions applied to the hamstring muscle group. The fourth group, which will serve as the control group, will not change their physical activity habits.', 'interventionNames': ['Other: Nordic Hamstring Exercises + SIS stimulation']}, {'label': 'Plyometric traning + SIS stimulation', 'description': 'The participants will be randomly assigned to four research groups. The first research group will undergo a four-week plyometric training program combined with Super Inductive Stimulation applied to the hamstring muscle group. The second research group will perform a four-week plyometric training program. The third research group will undergo a four-week series of Super Inductive Stimulation sessions applied to the hamstring muscle group. The fourth group, which will serve as the control group, will not change their physical activity habits.', 'interventionNames': ['Other: Plyometric traning + SIS stimulation']}, {'label': 'Neuromuscular traning + SIS stimulation', 'description': 'The participants will be randomly assigned to four research groups. The first research group will undergo a four-week neuromuscular training program combined with Super Inductive Stimulation applied to the hamstring muscle group. The second research group will perform a four-week neuromuscular training program. The third research group will undergo a four-week series of Super Inductive Stimulation sessions applied to the hamstring muscle group. The fourth group, which will serve as the control group, will not change their physical activity habits.', 'interventionNames': ['Other: Neuromuscular traning + SIS stimulation']}, {'label': 'Super Inductive Stimulation (SIS) Intervention', 'description': 'Super Inductive Stimulation (SIS) uses a high-intensity electromagnetic field (28 kT/s). The stimulus, induced by a coil placed in the applicator, generates depolarization of neuromuscular tissue. As a result, SIS evokes an action potential in the neuromuscular tissue, leading to the strengthening of weakened muscles. Due to the methodology of this intervention, the procedures are performed once per week over a period of 4 weeks.', 'interventionNames': ['Other: Super Inductive Stimulation (SIS) Intervention']}], 'interventions': [{'name': 'Nordic Hamstring Exercises + SIS stimulation', 'type': 'OTHER', 'description': 'Nordic Hamstring Exercise training lasts 4 weeks, during which the participant performs 3 sets, each consisting of 3 repetitions of the NHE. After each set, a 2-minute passive rest period follows, during which the participant recovers. In the first week, the participant trains under the supervision of the instructor, while in the following three weeks the exercises are performed at home after prior instruction.', 'armGroupLabels': ['Nordic Hamstring Exercises + SIS stimulation']}, {'name': 'Plyometric traning + SIS stimulation', 'type': 'OTHER', 'description': 'The intervention lasts 4 weeks, during which participants train three times per week. The program consists of single-leg and double-leg jumps, vertical jumps, lateral jumps, and forward jumps, all performed on a stable surface. A principle of progressive overload is applied, with gradual increases in training intensity, volume, and jump height. The progression begins with lower intensity exercises, single-joint movements, and less complex techniques, and advances to higher intensity exercises, multi-joint movements, and more complex techniques.', 'armGroupLabels': ['Plyometric traning + SIS stimulation']}, {'name': 'Neuromuscular traning + SIS stimulation', 'type': 'OTHER', 'description': 'The intervention lasts 4 weeks, with participants training three times per week. The program focuses on improving dynamic stability and incorporates the use of BOSU equipment. Exercises include multitask movements performed on unstable surfaces as well as exercises with eyes closed. During the first week, exercises are performed on a stable surface to improve balance while standing on one leg with eyes open and closed. In the following weeks, exercises on unstable surfaces are introduced, emphasizing the maintenance of proper posture on either one or both legs during multitask activities. In the third week, dynamic exercises on unstable surfaces are added, such as single-leg squats. In the final week, jumps and hops are incorporated. To further increase difficulty, additional load is introduced in the form of medicine balls weighing between 2 and 8 kilograms.', 'armGroupLabels': ['Neuromuscular traning + SIS stimulation']}, {'name': 'Super Inductive Stimulation (SIS) Intervention', 'type': 'OTHER', 'description': 'uses a high-intensity electromagnetic field (28 kT/s). The stimulus, induced by a coil placed in the applicator, generates depolarization of neuromuscular tissue', 'armGroupLabels': ['Super Inductive Stimulation (SIS) Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-336', 'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Ewelina Perzanowska, PhD', 'role': 'CONTACT', 'email': 'ewelina.perzanowska@awf.gda.pl', 'phone': '791597673'}], 'facility': 'Gdansk University of Physical Education and Sport', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'centralContacts': [{'name': 'Ewelina Perzanowska, PhD', 'role': 'CONTACT', 'email': 'ewelina.perzanowska@awf.gda.pl', 'phone': '791597673'}], 'overallOfficials': [{'name': 'Ewelina Perzanowska, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Kinesytherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gdansk University of Physical Education and Sport', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ewelina Perzanowska', 'investigatorAffiliation': 'Gdansk University of Physical Education and Sport'}}}}