Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:27 AM
Study NCT ID:
NCT07319702
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2025-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proprioceptive Neuromuscular Facilitation Combined With Spiral Muscle Chain Training for Pediatric Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-01', 'size': 1569558, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-12-20T02:43', 'hasProtocol': True}, {'date': '2024-03-01', 'size': 188608, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-12-20T02:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-20', 'studyFirstSubmitDate': '2025-12-20', 'studyFirstSubmitQcDate': '2025-12-20', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Trunk Tilt Angle (ATI)', 'timeFrame': 'Baseline and after 12 weeks of intervention', 'description': 'Trunk tilt angle (Angle of Trunk Rotation, ATI) measured using an electronic spine assessment device to evaluate changes in spinal asymmetry and trunk alignment.'}, {'measure': 'Change in Body Balance Parameters', 'timeFrame': 'Baseline and after 12 weeks of intervention', 'description': 'Body balance parameters assessed by electronic spine measurement, including head lateral deviation, shoulder asymmetry, and pelvic tilt.'}, {'measure': 'Change in Paraspinal Muscle Endurance', 'timeFrame': 'Baseline and after 12 weeks of intervention', 'description': 'Paraspinal muscle endurance evaluated during the Biering-Sorensen test using surface electromyography-derived fatigue indicators.'}], 'secondaryOutcomes': [{'measure': 'Change in Spinal Mobility', 'timeFrame': 'Baseline and after 12 weeks of intervention', 'description': 'Spinal mobility assessed by electronic spine measurement, including lateral flexion, flexion-extension, and rotational range of motion.'}, {'measure': 'Change in Surface Electromyography Parameters', 'timeFrame': 'Baseline and after 12 weeks of intervention', 'description': 'Surface electromyography (sEMG) parameters including EMG amplitude, integrated EMG (iEMG), slope of median frequency (SlopeMF), and slope of mean power frequency (SlopeMPF) recorded from bilateral trapezius, erector spinae, and multifidus muscles.'}, {'measure': 'Change in Trunk Muscle Activation Patterns', 'timeFrame': 'Baseline and after 12 weeks of intervention', 'description': 'Trunk muscle activation patterns assessed during standardized functional tasks using surface electromyography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent Idiopathic Scoliosis', 'Proprioceptive Neuromuscular Facilitation', 'Spiral Muscle Chain Training', 'Exercise Therapy', 'Rehabilitation'], 'conditions': ['Adolescent Idiopathic Scoliosis (AIS)']}, 'referencesModule': {'references': [{'pmid': '41263915', 'type': 'RESULT', 'citation': 'Xu Y, Feng M, Wu R, Wang Y, Yang Z, Wang Z, Kang Z, Xie L, Liu H. Effect of adding proprioceptive neuromuscular facilitation to conventional physiotherapy on scapular balance and shoulder proprioception in adolescents with idiopathic scoliosis: a randomised controlled trial protocol. BMJ Open. 2025 Nov 19;15(11):e106848. doi: 10.1136/bmjopen-2025-106848.'}, {'pmid': '34657873', 'type': 'RESULT', 'citation': 'Nechvatal P, Hitrik T, Kendrova LD, Macej M. Comparison of the effect of the McKenzie method and spiral stabilization in patients with low back pain: A prospective, randomized clinical trial. J Back Musculoskelet Rehabil. 2022;35(3):641-647. doi: 10.3233/BMR-210055.'}, {'pmid': '14713588', 'type': 'RESULT', 'citation': 'Maruyama T, Kitagawa T, Takeshita K, Mochizuki K, Nakamura K. Conservative treatment for adolescent idiopathic scoliosis: can it reduce the incidence of surgical treatment? Pediatr Rehabil. 2003 Jul-Dec;6(3-4):215-9. doi: 10.1080/13638490310001642748.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the clinical effectiveness of proprioceptive neuromuscular facilitation (PNF) combined with spiral muscle chain (SPS) training in improving spinal function and posture in children with adolescent idiopathic scoliosis.\n\nThe main questions it aims to answer are:\n\nDoes PNF combined with SPS training improve trunk alignment and body balance parameters in children with mild adolescent idiopathic scoliosis?\n\nDoes the combined intervention improve spinal mobility and paraspinal muscle endurance compared with single-intervention approaches?\n\nDoes the combined intervention lead to favorable changes in surface electromyography (sEMG) indicators of trunk and paraspinal muscles?\n\nResearchers will compare a PNF therapy group, an SPS training group, and a combined PNF + SPS group to assess differences in spinal alignment, muscle endurance, and neuromuscular activation outcomes.\n\nParticipants will:\n\nBe assigned to one of three intervention groups: PNF therapy alone, SPS training alone, or combined PNF and SPS training\n\nParticipate in supervised exercise training sessions three times per week for 12 weeks\n\nUndergo pre- and post-intervention assessments, including electronic spinal measurements and surface electromyography testing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age 13 to 18 years\n\nAngle of trunk rotation (ATR) 5° ≤ ATR \\< 10°\n\nNo brace treatment and no history of spinal surgery\n\nAble to complete PNF therapy and SPS training as required\n\nWritten informed consent obtained (participants and their parents/guardians)\n\nExclusion Criteria:\n\n* Non-idiopathic scoliosis\n\nAny exercise-related contraindications\n\nHistory of spinal surgery\n\nAny congenital deformity\n\nAny trauma within the previous 6 months\n\nAny accompanying neurological, rheumatological, or mental problems'}, 'identificationModule': {'nctId': 'NCT07319702', 'briefTitle': 'Proprioceptive Neuromuscular Facilitation Combined With Spiral Muscle Chain Training for Pediatric Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Normal University'}, 'officialTitle': 'Clinical Effects of Proprioceptive Neuromuscular Facilitation Combined With Spiral Muscle Chain Training in the Treatment of Children With Scoliosis', 'orgStudyIdInfo': {'id': 'NNU202410016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proprioceptive Neuromuscular Facilitation (PNF) Therapy', 'description': 'Participants receive proprioceptive neuromuscular facilitation (PNF) therapy as an exercise intervention for abnormal spinal curvature. Training is conducted 3 times per week (every other day) for 12 weeks. The PNF protocol includes resisted scapular-pelvic patterns, cervical flexion/extension, trunk chopping/lifting patterns, bilateral upper-limb patterns, and bridge exercises (per PNF schedule).', 'interventionNames': ['Behavioral: Proprioceptive Neuromuscular Facilitation (PNF) Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Spiral Muscle Chain (SPS) Training', 'description': 'Participants receive spiral stabilizing muscle chain (SPS) training as an exercise intervention for abnormal spinal curvature. Training is conducted 3 times per week (every other day) for 12 weeks. The SPS program follows the SPS training schedule (Training 1A-6A, 7C-10C, and stretching component), with planned repetitions/sets and practice time as listed in the protocol schedule.', 'interventionNames': ['Behavioral: Spiral Muscle Chain (SPS) Training']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Exercise Therapy', 'description': 'Participants receive a combined program consisting of PNF therapy plus SPS spiral muscle chain training as an exercise intervention for abnormal spinal curvature. Training is conducted 3 times per week (every other day) for 12 weeks.', 'interventionNames': ['Behavioral: Combined Exercise Therapy']}], 'interventions': [{'name': 'Proprioceptive Neuromuscular Facilitation (PNF) Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Proprioceptive Neuromuscular Facilitation'], 'description': 'Proprioceptive neuromuscular facilitation (PNF) therapy is used as an exercise-based intervention to address abnormal spinal curvature in children with adolescent idiopathic scoliosis.\n\nThe PNF program includes resisted scapular-pelvic patterns, cervical flexion and extension, trunk diagonal patterns (chopping and lifting), bilateral upper-limb diagonal patterns, and bridge exercises.\n\nTraining sessions are supervised and conducted three times per week (every other day) for 12 weeks.', 'armGroupLabels': ['Proprioceptive Neuromuscular Facilitation (PNF) Therapy']}, {'name': 'Spiral Muscle Chain (SPS) Training', 'type': 'BEHAVIORAL', 'otherNames': ['Spiral Stabilization Training'], 'description': 'Spiral muscle chain (SPS) training is applied as an exercise-based intervention aimed at improving spinal alignment, postural control, and neuromuscular coordination in children with adolescent idiopathic scoliosis.\n\nThe SPS program consists of spiral stabilization exercises performed with elastic resistance, body positioning control, and stretching components according to a standardized training protocol.\n\nTraining sessions are supervised and conducted three times per week (every other day) for 12 weeks.', 'armGroupLabels': ['Spiral Muscle Chain (SPS) Training']}, {'name': 'Combined Exercise Therapy', 'type': 'BEHAVIORAL', 'description': 'The combined intervention integrates proprioceptive neuromuscular facilitation (PNF) therapy and spiral muscle chain (SPS) training as a comprehensive exercise program for children with adolescent idiopathic scoliosis.\n\nParticipants perform both PNF and SPS exercise components within each training cycle to target spinal alignment, muscle endurance, and neuromuscular activation.\n\nTraining sessions are supervised and conducted three times per week (every other day) for 12 weeks.', 'armGroupLabels': ['Combined Exercise Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210023', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated High School of Nanjing Normal University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data (IPD) will not be shared because the study involves minors, and the data include sensitive health information related to spinal posture and neuromuscular function. According to the approved ethics protocol, strict measures are required to protect participants' privacy and confidentiality. Although all data are de-identified, sharing IPD may still pose a potential risk of re-identification. Therefore, IPD will not be made publicly available in order to ensure compliance with ethical requirements and data protection regulations."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nie danning', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Nie danning', 'investigatorAffiliation': 'Nanjing Normal University'}}}}