Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-04 @ 10:43 PM
Study NCT ID:
NCT02773160
Status:
UNKNOWN
Last Update Posted:
2016-05-16
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-05-13', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lumbopelvic kinematics from baseline to immediately post-intervention', 'timeFrame': 'Day 1, immediately post-intervention', 'description': 'Kinematics will be assessed using motion sensors that are mounted on the skin at the spinous processes of L1 and S1, and at the femur.'}], 'secondaryOutcomes': [{'measure': 'usefulness of feedback (Numeric rating scale 0-10)', 'timeFrame': 'Day 1, immediately post-intervention', 'description': 'How useful was the feedback that was provided to the subjects during the exercise trials?'}, {'measure': 'Pain during the exercise trials (Numeric rating scale 0-10)', 'timeFrame': 'Day 1, immediately post-intervention', 'description': 'Outcome measure primarily used as possible covariate'}, {'measure': 'Fear of low back pain during the exercise trials (Numeric rating scale 0-10)', 'timeFrame': 'Day 1, immediately post-intervention', 'description': 'Outcome measure primarily used as possible covariate'}, {'measure': 'Fear of damaging the lumbar spine during the exercise trials (numeric rating scale 0-10)', 'timeFrame': 'Day 1, immediately post-intervention', 'description': 'Outcome measure primarily used as possible covariate'}, {'measure': 'Borg-scale to measure fatigue during the exercise trials', 'timeFrame': 'Day 1, immediately post-intervention', 'description': 'Outcome measure primarily used as possible covariate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Non-specific Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '39274238', 'type': 'DERIVED', 'citation': 'Matheve T, Timmermans A, Danneels L, De Baets L. Task-Specific Perceived Harmfulness Predicts Protective Movement Behaviour in Chronic Low Back Pain. J Clin Med. 2024 Aug 25;13(17):5025. doi: 10.3390/jcm13175025.'}, {'pmid': '30253807', 'type': 'DERIVED', 'citation': 'Matheve T, Brumagne S, Demoulin C, Timmermans A. Sensor-based postural feedback is more effective than conventional feedback to improve lumbopelvic movement control in patients with chronic low back pain: a randomised controlled trial. J Neuroeng Rehabil. 2018 Sep 26;15(1):85. doi: 10.1186/s12984-018-0423-6.'}]}, 'descriptionModule': {'briefSummary': 'A large subgroup of patients with chronic non-specific low back pain have motor control impairments. During motor control exercises, different forms of external feedback can be used to support training. This randomized controlled trial will investigate the effectiveness of different forms of external feedback during the learning phase of a motor control task for the lumbar spine in healthy subjects and patients with chronic non-specific low back pain (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized into three groups: one group will receive feedback from motion sensors, one group from a mirror and one group will receive no feedback (control group). A single session intervention with measurements at baseline and immediately post-intervention will be used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic non-specific low back pain\n* Age 18-65\n* Able to understand Dutch\n\nExclusion Criteria:\n\n* Subjects that received lumbar stabilization exercises in the past year\n* Spinal surgery in the past\n* Pregnancy\n* Serious underlying pathologies (e.g. multiple sclerosis, tumors,…)\n* Signs or symptoms of nerve root involvement\n* Any physical condition at the moment of testing that can interfere with activities of daily living (e.g. serious knee pain)\n* Known skin-allergy for tape\n* BMI \\> 30kg/m²'}, 'identificationModule': {'nctId': 'NCT02773160', 'briefTitle': 'Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AcuteLearningEffects'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensor-based postural feedback', 'description': 'Subjects will receive visual feedback on a computer screen while practicing the motor control task. The feedback is based on information from from motion sensors that mointor the movements of the lumbar spine', 'interventionNames': ['Other: Sensor-based postural feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Mirror Feedback', 'description': 'Subjects will receive feedback from a mirror while practicing the motor control task', 'interventionNames': ['Other: Mirror feedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Subjects will receive no feedback while practicing the motor control task', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Sensor-based postural feedback', 'type': 'OTHER', 'description': 'Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task', 'armGroupLabels': ['Sensor-based postural feedback']}, {'name': 'Mirror feedback', 'type': 'OTHER', 'description': 'Subjects will receive feedback from a mirror during the learning phase of a motor control task', 'armGroupLabels': ['Mirror Feedback']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Subjects will receive no feedback during the learning phase of a motor control task', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3590', 'city': 'Diepenbeek', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'thomas Matheve, drs.', 'role': 'CONTACT'}, {'name': 'Martine Timmermans, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universiteit Hasselt', 'geoPoint': {'lat': 50.90769, 'lon': 5.41875}}, {'zip': '3500', 'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Thomas Matheve, drs.', 'role': 'CONTACT'}, {'name': 'Enzo Olivieri, dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'centralContacts': [{'name': 'Thomas Matheve, drs.', 'role': 'CONTACT', 'email': 'Thomas.Matheve@UHasselt.be'}, {'name': 'Annick Timmermans, prof. dr.', 'role': 'CONTACT', 'email': 'Annick.Timmermans@uhasselt.be'}], 'overallOfficials': [{'name': 'Annick Timmermans, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}, {'name': 'Enzo Olivieri, dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Jessa Ziekenhuis, Hasselt, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Annick Timmermans', 'investigatorAffiliation': 'Hasselt University'}}}}