Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT02938169
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2016-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jseok337@snu.ac.kr', 'phone': '+82-10-4382-2328', 'title': 'Dr. Juseok Ryu', 'organization': 'Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12weeks', 'description': 'This study did not exceed the minimal risk, so a data safety monitoring plan would not be needed.\n\nThere were no adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise with bracing exercise\n\n* walking exercise: treadmill gait with tolerable gait speed\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stabilization Exercise Group', 'description': "\\*\\* stabilization exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.", 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Walking and Stabilization Exercise Group', 'description': "\\*\\*walking exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.\n* walking exercise:treadmill gait with tolerable gait speed", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Flexibility Exercise Group', 'description': "\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don't educate the walking exercise method and stabilization exercise method", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Low Back Pain at Resting Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise\n\n•walking exercise: treadmill gait with tolerable gait speed'}, {'id': 'OG001', 'title': 'Stabilization Exercise Group', 'description': '\\*\\* stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n-bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as'}, {'id': 'OG002', 'title': 'Walking and Stabilization Exercise Group', 'description': '\\*\\*walking exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* walking exercise:treadmill gait with tolerable gait speed\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n-bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and i'}, {'id': 'OG003', 'title': 'Flexibility Exercise Group', 'description': '\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don\'t educate the walking exercise method and stabilization exercise method\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}], 'classes': [{'title': 'Pre-exercise', 'categories': [{'measurements': [{'value': '30.58', 'spread': '20.92', 'groupId': 'OG000'}, {'value': '37.50', 'spread': '21.76', 'groupId': 'OG001'}, {'value': '30.00', 'spread': '30.38', 'groupId': 'OG002'}, {'value': '41.92', 'spread': '23.32', 'groupId': 'OG003'}]}]}, {'title': 'After 6 weeks', 'categories': [{'measurements': [{'value': '25.00', 'spread': '20.10', 'groupId': 'OG000'}, {'value': '24.25', 'spread': '20.21', 'groupId': 'OG001'}, {'value': '18.33', 'spread': '20.93', 'groupId': 'OG002'}, {'value': '27.89', 'spread': '18.54', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Pre-Exercise and 6 weeks', 'description': 'numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Disability for Low Back Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise with bracing exercise\n\n* walking exercise: treadmill gait with tolerable gait speed\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}, {'id': 'OG001', 'title': 'Stabilization Exercise Group', 'description': '\\*\\* stabilization exercise with bracing exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n-bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to'}, {'id': 'OG002', 'title': 'Walking and Stabilization Exercise Group', 'description': '\\*\\*walking exercise, bracing exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* walking exercise:treadmill gait with tolerable gait speed\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n-bracing exercise: patient is instructed as follows: "Draw your navel up towar'}, {'id': 'OG003', 'title': 'Flexibility Exercise Group', 'description': '\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don\'t educate the walking exercise method and stabilization exercise method\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}], 'classes': [{'title': 'Pre-exercise', 'categories': [{'measurements': [{'value': '28.1', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '12.9', 'groupId': 'OG002'}, {'value': '38.0', 'spread': '21.1', 'groupId': 'OG003'}]}]}, {'title': 'After 6 weeks', 'categories': [{'measurements': [{'value': '22.5', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '12.3', 'groupId': 'OG002'}, {'value': '31.9', 'spread': '18.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Pre-Exercise and 6 weeks', 'description': "Oswestry disability index(ODI) (Unit: Point) The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.\\[", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale of Low Back Pain During Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise with bracing exercise\n\n* walking exercise: treadmill gait with tolerable gait speed\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}, {'id': 'OG001', 'title': 'Stabilization Exercise Group', 'description': "\\*\\* stabilization exercise with bracing exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."}, {'id': 'OG002', 'title': 'Walking and Stabilization Exercise Group', 'description': "\\*\\*walking exercise, bracing exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.\n* walking exercise:treadmill gait with tolerable gait speed"}, {'id': 'OG003', 'title': 'Flexibility Exercise Group', 'description': '\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don\'t educate the walking exercise method and stabilization exercise method\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.00', 'spread': '17.58', 'groupId': 'OG000'}, {'value': '22.50', 'spread': '23.72', 'groupId': 'OG001'}, {'value': '20.83', 'spread': '26.44', 'groupId': 'OG002'}, {'value': '32.50', 'spread': '21.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 week to 6weeks', 'description': "visual analog scale of low back pain during resting status at 0 week and 6 week Record 'no pain' on the left side of the line as 'unpaid pain' on the right side and indicate the degree of pain in the subject(0 to 100) 0 is equated with 'no pain' and 100 is 'unpaid pain'", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Strength(Endurance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise with bracing exercise\n\n* walking exercise: treadmill gait with tolerable gait speed\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}, {'id': 'OG001', 'title': 'Stabilization Exercise Group', 'description': '\\*\\* stabilization exercise with bracing exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}, {'id': 'OG002', 'title': 'Walking and Stabilization Exercise Group', 'description': "\\*\\*walking exercise, bracing exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.\n* walking exercise:treadmill gait with tolerable gait speed"}, {'id': 'OG003', 'title': 'Flexibility Exercise Group', 'description': '\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don\'t educate the walking exercise method and stabilization exercise method\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}], 'classes': [{'title': 'Pre-exercise', 'categories': [{'measurements': [{'value': '29.86', 'spread': '13.53', 'groupId': 'OG000'}, {'value': '51.45', 'spread': '12.40', 'groupId': 'OG001'}, {'value': '35.14', 'spread': '20.64', 'groupId': 'OG002'}, {'value': '41.25', 'spread': '15.31', 'groupId': 'OG003'}]}]}, {'title': 'After 6 weeks', 'categories': [{'measurements': [{'value': '43.30', 'spread': '18.83', 'groupId': 'OG000'}, {'value': '45.06', 'spread': '14.01', 'groupId': 'OG001'}, {'value': '43.79', 'spread': '17.81', 'groupId': 'OG002'}, {'value': '50.06', 'spread': '16.65', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Pre-Exercise and 6 weeks', 'description': 'endurances of specific posture (sec) (supine, side-lying and prone)', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise with bracing exercise\n\n* walking exercise: treadmill gait with tolerable gait speed\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}, {'id': 'OG001', 'title': 'Stabilization Exercise Group', 'description': '\\*\\* stabilization exercise with bracing exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}, {'id': 'OG002', 'title': 'Walking and Stabilization Exercise Group', 'description': '\\*\\*walking exercise, bracing exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* walking exercise:treadmill gait with tolerable gait speed\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed'}, {'id': 'OG003', 'title': 'Flexibility Exercise Group', 'description': '\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don\'t educate the walking exercise method and stabilization exercise method\n\nexercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)'}], 'classes': [{'title': 'Pre-exercise', 'categories': [{'measurements': [{'value': '10.5', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '12.3', 'spread': '7.6', 'groupId': 'OG003'}]}]}, {'title': 'After 6 weeks', 'categories': [{'measurements': [{'value': '8.6', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '6.2', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '9.2', 'groupId': 'OG002'}, {'value': '10.8', 'spread': '6.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': "Beck depression inventory consisted of 21 questions about how the subject has been feeling in the last week. Each question had a set of four possible responses, ranging in intensity(0 is weak and 3 is severe). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The total score is 63, higher total scores indicate more severe depressive symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise\n\n•walking exercise: treadmill gait with tolerable gait speed'}, {'id': 'FG001', 'title': 'Stabilization Exercise Group', 'description': "\\*\\* stabilization exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."}, {'id': 'FG002', 'title': 'Walking and Stabilization Exercise Group', 'description': "\\*\\*walking exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.\n* walking exercise:treadmill gait with tolerable gait speed"}, {'id': 'FG003', 'title': 'Flexibility Exercise Group', 'description': "\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don't educate the walking exercise method and stabilization exercise method"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Walking Exercise Group', 'description': '\\*\\*walking exercise\n\n•walking exercise: treadmill gait with tolerable gait speed'}, {'id': 'BG001', 'title': 'Stabilization Exercise Group', 'description': "\\*\\* stabilization exercise\n\n•stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition."}, {'id': 'BG002', 'title': 'Walking and Stabilization Exercise Group', 'description': "\\*\\*walking exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.\n* walking exercise:treadmill gait with tolerable gait speed"}, {'id': 'BG003', 'title': 'Flexibility Exercise Group', 'description': "\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don't educate the walking exercise method and stabilization exercise method"}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.15', 'spread': '13.89', 'groupId': 'BG000'}, {'value': '57.40', 'spread': '15.88', 'groupId': 'BG001'}, {'value': '54.75', 'spread': '14.98', 'groupId': 'BG002'}, {'value': '53.54', 'spread': '15.69', 'groupId': 'BG003'}, {'value': '54.81', 'spread': '14.66', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-30', 'size': 66476, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-03T03:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2016-10-13', 'resultsFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-20', 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low Back Pain at Resting Status', 'timeFrame': 'Baseline Pre-Exercise and 6 weeks', 'description': 'numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain).'}, {'measure': 'Disability for Low Back Pain', 'timeFrame': 'Baseline Pre-Exercise and 6 weeks', 'description': "Oswestry disability index(ODI) (Unit: Point) The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.\\["}, {'measure': 'Visual Analog Scale of Low Back Pain During Rest', 'timeFrame': '0 week to 6weeks', 'description': "visual analog scale of low back pain during resting status at 0 week and 6 week Record 'no pain' on the left side of the line as 'unpaid pain' on the right side and indicate the degree of pain in the subject(0 to 100) 0 is equated with 'no pain' and 100 is 'unpaid pain'"}], 'secondaryOutcomes': [{'measure': 'Muscle Strength(Endurance)', 'timeFrame': 'Baseline Pre-Exercise and 6 weeks', 'description': 'endurances of specific posture (sec) (supine, side-lying and prone)'}, {'measure': 'Depression Scale', 'timeFrame': '6 weeks', 'description': "Beck depression inventory consisted of 21 questions about how the subject has been feeling in the last week. Each question had a set of four possible responses, ranging in intensity(0 is weak and 3 is severe). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The total score is 63, higher total scores indicate more severe depressive symptoms."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'exercise', 'electromyography'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '25122093', 'type': 'RESULT', 'citation': 'Lee HI, Lee ST, Kim M, Ryu JS. Sex differences in predicting chronicity of low-back pain after acute trauma using lumbar muscle area. Am J Phys Med Rehabil. 2015 Feb;94(2):123-30. doi: 10.1097/PHM.0000000000000149.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.', 'detailedDescription': '* Design: Prospective study\n* Setting: hospital rehabilitation department\n* Intervention: Participants are randomly assigned 4 different exercise group: flexibility exercise, bracing exercise + stabilization exercise group, bracing exercise+ walking exercise group and bracing+ walking + stabilization exercise group\n* Main outcome measures: Numeric rating scale(NRS), Oswestry disability index Peak torque of lumbar extensor by surface electromyography Time duration of capability of maintenance the posture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Age\\>20\n * Who suffered low back pain more than 3 months.\n* Exclusion Criteria:\n\n * Pregnancy\n * Under 20-year-old\n * Who have significant neurologic deficit\n * Who experienced spine operation\n * Who cannot walking'}, 'identificationModule': {'nctId': 'NCT02938169', 'acronym': 'EMG', 'briefTitle': 'The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis', 'orgStudyIdInfo': {'id': 'B-1604-344-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'walking exercise group', 'description': '\\*\\*walking exercise with bracing exercise\n\n* walking exercise: treadmill gait with tolerable gait speed\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."', 'interventionNames': ['Behavioral: exercise']}, {'type': 'EXPERIMENTAL', 'label': 'stabilization exercise group', 'description': '\\*\\* stabilization exercise with bracing exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."', 'interventionNames': ['Behavioral: exercise']}, {'type': 'EXPERIMENTAL', 'label': 'walking and stabilization exercise group', 'description': '\\*\\*walking exercise, bracing exercise with stabilization exercise\n\n* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise:treadmill gait with tolerable gait speed', 'interventionNames': ['Behavioral: exercise']}, {'type': 'SHAM_COMPARATOR', 'label': 'flexibility exercise group', 'description': "\\*\\*Stretching exercise(control)\n\n* Only educate the flexibility exercise(stretching exercise)\n* Don't educate the walking exercise method and stabilization exercise method", 'interventionNames': ['Behavioral: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': '* stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient\'s specific condition.\n* bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this."\n* walking exercise: treadmill gait with tolerable gait speed\n* flexibility exercise: stretching exercise(control)', 'armGroupLabels': ['flexibility exercise group', 'stabilization exercise group', 'walking and stabilization exercise group', 'walking exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Kyungji-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Juseok Ryu, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Ju Seok Ryu', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}