Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 5:40 PM
Study NCT ID:
NCT04008459
Status:
TERMINATED
Last Update Posted:
2020-09-14
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Walking and Balance Related to Sagittal Spinal Posture Alignment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007738', 'term': 'Kyphosis'}, {'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment no longer viable as spinal classes were stopped due to the COVID-19 situation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sagittal spinal alignment', 'timeFrame': '6 weeks post-baseline', 'description': 'Alignment of the spine in the sagittal plane measured by a surface topography method'}], 'secondaryOutcomes': [{'measure': 'Sagittal spinal alignment', 'timeFrame': '6 months', 'description': 'Alignment of the spine in the sagittal plane measured by a surface topography method'}, {'measure': '2 minute walk test', 'timeFrame': '6 weeks and 6 months', 'description': 'Distance walked in 2 minutes to measure exercise capacity'}, {'measure': 'Gait analysis', 'timeFrame': '6 weeks and 6 months', 'description': 'Spatiotemoral gait parameters measured using inertial measurement units'}, {'measure': 'Tragus to wall distance', 'timeFrame': '6 weeks and 6 months', 'description': 'Forward posture measurement using the distance from the ear to the wall'}, {'measure': 'Four Square Step Test', 'timeFrame': '6 weeks and 6 months', 'description': 'Dynamic balance test involving multidirectional stepping over obstacles'}, {'measure': 'Timed loaded standing test', 'timeFrame': '6 weeks and 6 months', 'description': 'Measurement of back extensor muscle strength and endurance'}, {'measure': '36-item Short Form Health Survey (SF-36)', 'timeFrame': '6 weeks and 6 months', 'description': 'Health survey measuring aspects of quality of life. The questionnaire contains 36 questions which form 8 subscales: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Each question is directly transformed into a 0-100 scale with the lower the score the more disability.'}, {'measure': 'Visual analogue pain scale', 'timeFrame': '6 weeks and 6 months', 'description': "Measurement of pain in a participant's back. The scale is along a horizontal 10 cm line with markings from 0 to 10, 0 indicating no pain and 10 indicating the worst pain imaginable."}, {'measure': 'Activities-specific Balance Confidence Scale', 'timeFrame': '6 weeks and 6 months', 'description': 'Questionnaire measuring balance confidence in various situations. It contains 16 questions in which participants rate their confidence in performing the activities on a scale from 0-100, 0 representing no confidence and 100 representing complete confidence. The total score is calculated to be on a similar 0 to 100 scale.'}, {'measure': 'Modified gait efficacy scale', 'timeFrame': '6 weeks and 6 months', 'description': 'Questionnaire measuring walking confidence and self-efficacy. Each of the 10 items is scored on a 10-point Likert scale with 1 representing no confidence and 10 representing complete confidence. The total score ranges from 10-100.'}, {'measure': 'Sagittal spinal alignment', 'timeFrame': 'Within 2 weeks of baseline', 'description': 'Reliability re-test of alignment of the spine in the sagittal plane measured by a surface topography method'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperkyphosis', 'Walking, Difficulty', 'Balance; Distorted', 'Spinal Disease', 'Osteoporosis', 'Spine Degeneration']}, 'descriptionModule': {'briefSummary': 'This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.', 'detailedDescription': "This prospective cohort study will include people who are attending physiotherapy to address a degenerative spinal condition and measure them longitudinally. The investigators will measure spinal alignment, walking capacity and pattern, dynamic balance, and back muscle strength along with self-reported measures that reflect the person's functional self-efficacy, quality of life, and general health. Physical and self-reported outcome measures will be assessed at baseline before the physiotherapy-led exercise class commences, after completion at 6 weeks, and 6 months post baseline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is diagnosed with a degenerative spinal condition.\n* Participant is willing and able to give informed consent for participation in the study.\n* Men and women aged 18 years or older.\n* Participant is able to understand and participate safely in a physiotherapy measurement assessment.\n* Participant is enrolled in physiotherapy.\n\nExclusion Criteria:\n\n* Participant is unable to stand independently.\n* Participant has a neurological condition which alters motor function and/or postural control.'}, 'identificationModule': {'nctId': 'NCT04008459', 'acronym': 'WiSPA', 'briefTitle': 'Walking and Balance Related to Sagittal Spinal Posture Alignment', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment', 'orgStudyIdInfo': {'id': '14031'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Degenerative musculoskeletal spinal conditions', 'description': 'Participants are included who are enrolled in a 6-week physiotherapy exercise class aimed at improving function in people with degenerative spinal conditions.', 'interventionNames': ['Other: Therapeutic exercise class']}], 'interventions': [{'name': 'Therapeutic exercise class', 'type': 'OTHER', 'description': 'Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions.', 'armGroupLabels': ['Degenerative musculoskeletal spinal conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX4 1TH', 'city': 'Oxford', 'state': 'Oxon', 'country': 'United Kingdom', 'facility': 'Nuffield Orthopaedic Centre', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Erin Hannink, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}