Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 4:17 AM
Study NCT ID:
NCT07483892
Status:
COMPLETED
Last Update Posted:
2026-03-19
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Cervical Sensorimotor Training With Pilates Reformer on Balance and Cervical Joint Position Sense
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This was an open-label study. Blinding was not feasible due to the nature of the exercise intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to one of three groups: (1) Pilates exercise combined with sensory integration training, (2) Pilates exercise only, or (3) a control group with no exercise intervention. The intervention were conducted for a specified period, and gait parameters were measured as outcome variables to evaluate the effects of the interventions on gait characteristics.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Static posture balance - plantar pressure distribution across foot quadrants', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Static posture balance assessed as plantar pressure distribution across four foot quadrants during quiet standing; values closer to 25% indicate better static posture balance.\n\nUnit of Measure: percent (%)'}, {'measure': 'Rearfoot alignment - resting calcaneal stance position (RCSP)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Rearfoot alignment assessed using RCSP in degrees. An angle of 0° is ideal (normal range: -2° to +2°), with positive values indicating valgus and negative values indicating varus.\n\nUnit of Measure: degrees (°)'}], 'primaryOutcomes': [{'measure': 'Title: Dynamic balance - COP medio-lateral excursion rate(COP ML Rate) during gait stance phase', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Dynamic postural control assessed as the COP medio-lateral rate during gait (COP medio-lateral distance (mm)/foot width (mm)x100); higher percentages indicate greater COP curvature, reflecting a more normal foot rollover pattern.\n\nUnit of Measure: percent (%)'}, {'measure': 'Dynamic balance - COP Sway Rate during gait stance phase', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Dynamic postural control assessed as COP Sway Rate during gait (Net Sway Length/COP Path Length × 100); values closer to 0% indicate better dynamic balance.\n\nUnit of Measure: percent (%)'}, {'measure': 'Dynamic balance - Y-Balance Test (YBT) composite score', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Dynamic balance assessed using Y-Balance Test score (% of limb length); higher values indicate better dynamic balance.\n\nUnit of Measure: percent (%)'}], 'secondaryOutcomes': [{'measure': 'Title: Static balance - COP Sway Distance during quiet standing', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Static postural stability assessed as the distance of center of pressure (COP) sway during quiet standing; values closer to 0 mm indicate better static balance.\n\nUnit of Measure: millimeters (mm)'}, {'measure': 'Static balance - COP ellipse area during quiet standing', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Static postural stability assessed as the area of the COP sway ellipse during quiet standing, with smaller areas indicating better static balance.\n\nUnit of Measure: square millimeters (mm²)'}, {'measure': 'Cervical Joint Position Sense(CJPS) - Accuracy', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Cervical Joint Position Sense-Accuracy assessed using the Cervical Joint Position Error Test (CJPET) as the mean absolute linear repositioning error over five repetitions to the left and five to the right; values closer to 0 cm indicate better cervical position sense.\n\nUnit of Measure: centimeters (cm)'}, {'measure': 'Cervical Joint Position Sense(CJPS) - Precision', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Cervical Joint Position Sense - Precision assessed using the CJPET as the standard deviation of linear repositioning error over five repetitions to the left and five to the right; values closer to 0 cm indicate better cervical position sense.\n\nUnit of Measure: centimeters (cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical joint position sense', 'sensorimotor training', 'Pilates exercise', 'visual feedback', 'balance'], 'conditions': ['Focus of Study is Effects of Neuromuscular Training', 'Postural Balance', 'Pilates']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Zarei, H., Norasteh, A. A., Rahmanpournashrudkoli, A. and Hajihoseini, E. (2020). The effects of Pilates training on static and dynamic balance of female deaf students: A randomized controlled trial. Journal of Bodywork and Movement Therapies, 24, 63-69.'}, {'type': 'BACKGROUND', 'citation': 'Wannaprom, N., Treleaven, J., Jull, G. and Uthaikhup, S. (2018). Neck muscle vibration produces diverse responses in balance and gait speed between individuals with and without neck pain. Musculoskeletal Science and Practice, 35, 25-29. https://doi.org/10.1016/j.msksp.2018.02.001'}, {'type': 'BACKGROUND', 'citation': 'Treleaven, J. (2017). Dizziness, unsteadiness, visual disturbances, and sensorimotor control in traumatic neck pain. Journal of Orthopaedic & Sports Physical Therapy, 47, 492-502. https://doi.org/10.2519/jospt.2017.7052'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of Pilates reformer exercise combined with cervical sensorimotor training using laser-guided visual feedback on balance performance. Participants were randomly assigned to three groups: a combined training group, a Pilates-only group, and a control group. Static and dynamic balance were assessed before and after the intervention.\n\nThis study was registered retrospectively on ClinicalTrials.gov after participant enrollment had begun. Institutional Review Board (IRB) approval was obtained prior to participant enrollment.', 'detailedDescription': 'Postural control is maintained through the integration of sensory information from the visual, vestibular, and somatosensory systems. Among these systems, cervical proprioception plays a critical role in providing information about head position and movement, which contributes to the regulation of balance and postural stability. Alterations or deficits in cervical proprioceptive input may negatively influence sensorimotor control and balance performance.\n\nLaser-guided visual feedback training has been used to enhance cervical joint position sense and improve sensorimotor control by providing real-time visual information about head and neck movements. This method allows individuals to actively adjust head position based on visual feedback, thereby facilitating proprioceptive retraining.\n\nThe reformer exercise method is a form of resistance-based exercise that emphasizes controlled movements, core stabilization, and neuromuscular coordination. Integrating cervical proprioceptive training with reformer exercise may further enhance postural control by promoting coordinated activation of trunk and neck musculature.\n\nThe purpose of this study is to investigate the effects of a reformer exercise program incorporating cervical proprioceptive training using laser-guided visual feedback on balance ability. Pilates Reformer-based exercises combined with cervical proprioceptive training tasks were proceeded. Balance performance and proprioception were evaluated using static and dynamic balance measures and cervical joint position error before and after the intervention.\n\nThe findings of this study may provide evidence regarding the potential benefits of integrating laser-guided visual feedback-based cervical proprioceptive training into exercise programs aimed at improving balance and postural stability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'Only female adults were included to reduce sex-related variability in balance and cervical proprioception measurements.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female adults aged 30-49 years\n* Individuals who use a computer for ≥6 hours per day\n* Individuals who have experienced musculoskeletal pain and discomfort (neck, shoulder, or lower back) within the past year\n* Individuals who voluntarily agreed to participate in the study\n* Individuals able to participate in exercise training\n\nExclusion Criteria:\n\n* History of musculoskeletal or neurological surgery within the past 6 months\n* Individuals diagnosed with severe fractures or neurological disorders requiring surgical treatment\n* Any severe condition affecting balance or gait'}, 'identificationModule': {'nctId': 'NCT07483892', 'briefTitle': 'Effects of Cervical Sensorimotor Training With Pilates Reformer on Balance and Cervical Joint Position Sense', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'The Effect of Cervical Sensorimotor Control Training Combined With Reformer Exercise on Static and Dynamic Balance and Cervical Joint Position Sense', 'orgStudyIdInfo': {'id': 'ewha-202108-CSP-balance'}, 'secondaryIdInfos': [{'id': 'IRB: ewha-202108-0034-01', 'type': 'OTHER', 'domain': 'Institutional Review Board of Ewha Womans University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical Sensorimotor Training with Pilates Reformer Exercise', 'description': 'Participants performed Pilates reformer exercise combined with cervical sensorimotor training using laser-guided visual feedback.', 'interventionNames': ['Behavioral: Cervical Sensorimotor Training', 'Behavioral: Pilates Reformer Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pilates-only Exercise Group', 'description': 'Participants performed a Pilates reformer exercise program without cervical sensorimotor training.', 'interventionNames': ['Behavioral: Pilates Reformer Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants had no intervention'}], 'interventions': [{'name': 'Cervical Sensorimotor Training', 'type': 'BEHAVIORAL', 'otherNames': ['laser-guided visual-vestibular-cervical sensorimotor training'], 'description': 'Laser-guided cervical sensorimotor training designed to improve cervical joint position sense. Training included head repositioning tasks with visual feedback under progressively challenging postural conditions involving different base-of-support and surface stability levels.', 'armGroupLabels': ['Cervical Sensorimotor Training with Pilates Reformer Exercise']}, {'name': 'Pilates Reformer Exercise', 'type': 'BEHAVIORAL', 'description': 'Pilates Reformer-based exercise focusing on trunk stabilization, postural alignment, controlled balance using spring-based resistance and different base-of-support.', 'armGroupLabels': ['Cervical Sensorimotor Training with Pilates Reformer Exercise', 'Pilates-only Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03760', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to privacy and ethical restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}