Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT03625193
Status:
UNKNOWN
Last Update Posted:
2019-03-12
First Post:
2018-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-10', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to perform single and five times sit-to-stand test among 4 arm conditions', 'timeFrame': 'Change over 6 months', 'description': 'Ability to execute a single time sit-to-stand and time used for five times sit-to-stand'}], 'secondaryOutcomes': [{'measure': '10-meter walk test', 'timeFrame': 'Change over 6 months', 'description': 'Change in walking speed during 6-month follow-up'}, {'measure': 'Fall events', 'timeFrame': 'Over 6 months', 'description': 'Incidence of fall during 6-month follow-up'}, {'measure': 'Global rating of change score (GRC score)', 'timeFrame': 'Change over 6 months', 'description': 'Level of change in subjects\' independence in activities of daily life. The GRC score is divided into 15-point scale from "-7" (a very great deal worse) to "0" (about the same/ not change) to "7" (a very great deal better).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sit-to-stand test', 'Psychometric properties'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': '1. Do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (STST) in ambulatory individuals with spinal cord injury (SCI)?\n2. What are the factors associated with ability to perform STST in ambulatory individuals with SCI?\n3. Are the single-time sit-to-stand test (STSST) and five-time sit-to-stand test (FTSST) reliable, valid and responsive to determine functional alteration in ambulatory individuals with SCI?', 'detailedDescription': '* To cross-sectionally compare characteristics (duration and amount of lower limb loading) of STS movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with SCI.\n* To investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the STSST and FTSST in ambulatory patients with SCI.\n* To investigate concurrent validity and factors associated with ability of the STSST and FTSST in ambulatory patients with SCI.\n* To investigate the ability of the STSST and FTSST to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with SCI.\n* To investigate internal and external responsiveness of the STSST and FTSST to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with SCI.\n* To estimate the minimal clinically important difference or clinical significance of the FTSST in ambulatory patients with SCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is conducted in patients with spinal cord injury who able to sit-to-stand independently with or without hand support from the Srinagarind hospital and communities in the Northeast areas of Thailand.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 18.5 - 29.9 kg/m2\n* Having an incomplete SCI from traumatic or non-traumatic causes\n* Ability of independent standing up from a chair with or without hand support\n* Ability of independent walking with or without walking device over at least 10 meters continuously.\n* Ability to follow commands used in the studies\n\nExclusion Criteria:\n\nAny ambulatory individuals with incomplete SCI who present signs and symptoms that might affect ability to perform STST will be excluded from the study such as\n\n* Pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (NRS)\n* Joint deformities that affect mobility\n* Other neurological disorders such as having brain lesions\n* Unstable medical conditions\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03625193', 'briefTitle': 'Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Appropriate Methods and Psychometric Properties of Sit-to-stand Test in Ambulatory Patients With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'PHD02232558'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ambulatory patients with SCI', 'description': '* Age at least 18 years\n* Body mass index (BMI) between 18.5 - 29.9 kg/m2\n* Having an incomplete SCI from traumatic or non-traumatic causes\n* Ability of independent standing up from a chair with or without hand support\n* Ability of independent walking with or without walking device over at least 10 meters continuously.\n* Ability to follow commands used in the studies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Lalita Khuna', 'role': 'CONTACT', 'email': 'lalitakhuna@gmail.com', 'phone': '+66637391999'}], 'facility': 'Faculty of Associated Medical Science, 123 Moo 16 Mittapap Rd., Nai-Muang, Muang District', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'centralContacts': [{'name': 'Lalita Khuna, PhD student', 'role': 'CONTACT', 'email': 'lalitakhuna@gmail.com', 'phone': '+66637391999'}], 'overallOfficials': [{'name': 'Sugalya Amatachaya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Sugalya Amatachaya', 'investigatorAffiliation': 'Khon Kaen University'}}}}