Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT03442660
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2017-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Spasticity Related Quality of Life Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2017-12-15', 'studyFirstSubmitQcDate': '2018-02-16', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of SQOL-6D in upper limb spasticity', 'timeFrame': 'Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)', 'description': 'Validity - Reliability - Responsiveness'}], 'secondaryOutcomes': [{'measure': 'EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels)', 'timeFrame': 'Day 1 and then 8 weeks +/-2', 'description': 'A summary index score will be calculated from responses given to the 5 domain items, measuring overall health on a scale 0 to 1 using United Kingdom (UK) value sets.'}, {'measure': 'Neurological Impairment Scale adapted for ULS (ULS-NIS)', 'timeFrame': 'Day 1', 'description': 'Records functional impairment on a four-point scale (rated 0-3) across seven domains, including: motor impairment in the affected upper limb, sensation affected in the affected upper limb, communication, cognitive function, cortical function, emotional/behaviour and mobility of joints, as measured by soft tissue shortening (an assessment used for the evaluation of the deterioration in range of movement due to spasticity by percentage loss of range).'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'Day 1 and then 8 weeks +/-2', 'description': 'Six-point scale (with available scores of 0, 1, 1+, 2, 3 and 4) evaluates muscle tone by reporting changes in this during muscle flexion or extension, depending on the (resistance in) joint mobility being assessed (shoulder, elbow, wrist or finger).'}, {'measure': 'Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity)', 'timeFrame': 'Day 1 and then 8 weeks +/-2', 'description': 'Goal attainment will be recorded on a five point numerical scale (range -2 to +2) and goal scores combined to give an aggregated T score.'}, {'measure': 'ArmA (Arm Activity Measure) Scores', 'timeFrame': 'Day 1 and then 8 weeks +/-2', 'description': 'ArmA is a patient-reported outcomes questionnaire recording the difficulty in caring for, and completing tasks and activities with the affected arm. The ArmA contains a total of 29 items in four subscales. Difficulty for each item is assessed on a five-point scale (range 0 to 4).'}, {'measure': 'Global assessment of benefit', 'timeFrame': '8 weeks +/-2', 'description': 'The Global Assessment of Benefit scale will be completed by the subject. Responses options will be: Much worse (-2)/Worse (-1)/Same (0)/Some benefit (+1)/Great benefit (+2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spasticity, Muscle']}, 'referencesModule': {'references': [{'pmid': '34726763', 'type': 'DERIVED', 'citation': 'Turner-Stokes L, Fheodoroff K, Jacinto J, Lambert J, De La Loge C, Calvi-Gries F, Whalen J, Lysandropoulos A, Maisonobe P, Ashford S. The spasticity-related quality of life 6-dimensions instrument in upper-limb spasticity: Part I Development and responsiveness. J Rehabil Med. 2022 Jan 3;54:jrm00244. doi: 10.2340/jrm.v53.690.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to describe the psychometric properties (validity, reliability and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of upper limb spasticity.', 'detailedDescription': 'The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection procedures include multiple questionnaire assessments and one on-site visit not necessarily part of routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently resident in the UK\n* Subjects with a diagnosis of ULS\n* Receiving a treatment at the enrolment visit, as part of their routine clinical management, aiming at reducing spasticity\n* Sufficient grasp of English and cognitive ability to be able to understand the SQOL-6D questions, give informed consent and complete the protocol requirements as judged by the investigator\n\nExclusion Criteria:\n\n* The subject has already been included in the study\n* The subject, in the opinion of the investigator, would be unable to understand the questionnaire or to comply with the requirements of the study'}, 'identificationModule': {'nctId': 'NCT03442660', 'acronym': 'SQOL-6D', 'briefTitle': 'Validation of the Spasticity Related Quality of Life Questionnaire', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Psychometric Validation Study of the Spasticity Quality of Life 6-Dimensions (SQOL-6D) in Upper-limb Spasticity', 'orgStudyIdInfo': {'id': 'F-FR-52120-232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Data collection', 'description': 'An electronic data capture (EDC) system will be used to collect data in electronic format. Data will be collected at the enrolment visit, at the follow-up visit (8 weeks +/-2 weeks) and 1 to 4 days after the follow-up visit.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': "Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional diagnostic or treatment procedures will be required. Subjects will be asked to complete electronic (or on paper when it's not possible to use electronic version) questionnaires.", 'armGroupLabels': ['Data collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'country': 'United Kingdom', 'facility': 'Hull and East Yorkshire NHS Trust, Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'WF13 4HS', 'city': 'Dewsbury', 'country': 'United Kingdom', 'facility': 'Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital', 'geoPoint': {'lat': 53.69076, 'lon': -1.62907}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'NE6 4QD', 'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'ST6 7AG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'CV34 6SR', 'city': 'Warwick', 'country': 'United Kingdom', 'facility': 'South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital', 'geoPoint': {'lat': 52.28333, 'lon': -1.58333}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}