Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT03962218
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'balance', 'timeFrame': '12 weeks', 'description': 'Berg test'}, {'measure': 'Speed of the gait', 'timeFrame': '12 weeks', 'description': 'test of 10 m'}, {'measure': 'Gait resistance', 'timeFrame': '12 weeks', 'description': '6 Minutes Walk Test'}, {'measure': 'Functional capacity of the gait', 'timeFrame': '12 weeks', 'description': 'Walking Index for spinal cord injury (WISCI II)'}], 'secondaryOutcomes': [{'measure': 'General quality of life related to Health', 'timeFrame': '12 weeks', 'description': 'Measures through the Questionnaire EuroQol-5D-5L. The questionnaire comprises 5 dimensions: mobility, self care, usual activities, pain discomfort, anxiety/depression. Each dimension is scored in 5 levels, 1-5 (level 1-no problem, level 5,-extreme problems). Based on the answers, a index value from 0 to 1 is calculated (0-the worst quality of life, 1-the best quality of life).'}, {'measure': 'Specific quality of life related to health in spinal cord injury', 'timeFrame': '12 weeks', 'description': 'Measured through the questionnaire "Spanish version of the Quality of Life Index in spinal cord injury (SV-QLI / SCI)". The questionnaire evaluates 37 items, in a scale from 1 (less satisfied) to 6 (most satisfied). There are 5 scores of 0-30 (0=less satisfied, 30=most satisfied) which are calculated using the subscales: 1-Total Quality of Life score. 2-Health and Functioning Subscale. 3-Social and Economic Subscale. 4-Psychological /Spiritual Subscale. 5-Family Subscale. The final score is an average of the subscale\'s scores, being between 0 (0=less satisfied) and 30 (30=most satisfied).'}, {'measure': 'Inflammatory cytokines analysis', 'timeFrame': '12 weeks', 'description': "Quantification of the cytokine concentration, in pg/mL, will be carried out by Luminex xMAP Bead-based multiplex Assay (Labclinics). Cytokine's panel includes the cytokines E-selectin, P-selectin, IL-1α, IL-1β, IL-10, MCP-1 (CCL2),GM-CSF, IL12p70, MIP-1α (CCL3), MIP-1β (CCL4), ICAM-1, IL-4, IL-13, IFN-α, IFN-γ, IL-6, IL-17A,(CTLA8), IL-8 (CXCL8), IP-10 (CXCL10) and TNF-α."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'Hydrotherapy', 'Balance', 'Gait'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '40163138', 'type': 'DERIVED', 'citation': 'Menchero R, Martinez-Galan I, Alcobendas-Maestro M, Romay-Barrero H, Fernandez-Maestra A, Gueita-Rodriguez J. Feasibility and impact of a Water Specific Therapy program in individuals with subacute incomplete spinal cord injury: A non-randomized controlled trial. J Spinal Cord Med. 2025 Nov;48(6):997-1005. doi: 10.1080/10790268.2025.2472098. Epub 2025 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the study: To analyse the effectiveness of aquatic physiotherapy on spinal cord injuries (LMi) in the improvement of balance and gait, in the inflammatory profile, and the impact on the quality of life.\n\nMain objective: To analyse if there are differences in the recovery of the balance, in incomplete subacute spinal cord injuries, with lesion level T1-L5 and ASIA (American Spinal Injury Association) C and D .\n\nSecondary objectives:\n\n1. functional gait\n2. To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait.\n3. To study the effect of aquatic therapy on serum markers of systemic inflammation.\n4. Quality of life related to health. Design: Crossed, controlled and randomized clinical trial, with blind evaluation of the response variables.\n\nScope of the study: National Hospital of Paraplegics. Toledo (Spain). Population: Subjects with incomplete spinal cord injury ASIA C and D. n = 50 (25 in each arm randomly).\n\nIntervention:\n\n6 weeks of specific Aquatic Physiotherapy (3 times a week). Group 1 will perform aquatic physiotherapy at the time of entering the study, and group 2 will perform it 6 weeks later.\n\nOutcomes: Static and dynamic balance (Berg test and Time Up and Go). Speed of the gait (test of 10 m.). Gait resistance (6 min. Test). Functional capacity of the gait (WISCI II). Biomechanical analysis (sensorial-dynamic, rhythmic and directional control, and gait test) by posturography. Questionnaires EuroQol-5Dimensions-5Level (EQ-5D-5L) and the Spanish Version of the Quality of Life Index (SV-QLI) in spinal cord injury (SCI).\n\nBiomarkers of inflammation: 20 cytokines. Analysis of results: The main outcome measure will be the percentage of patients who have improved. Considering improvement when the difference between the groups is, at least, a 10% of their score in the Berg test between V0 and V1 (with their corresponding 95% confidence intervals). It will be adjusted for confounding and interaction factors with a multivariate analysis using logistic regression. All analyses will be performed according to the intention to treat principle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with incomplete spinal cord injury T1-L5 (ASIA C y D).\n* Traumatic and not traumatic injuries, with injury date of less than 8 months.\n* Able to maintain assisted standing up\n* Subjects signing the informed consent form\n\nExclusion Criteria:\n\n* Subjects with progressive injuries.\n* heart or lung disease'}, 'identificationModule': {'nctId': 'NCT03962218', 'acronym': 'FALMI', 'briefTitle': 'Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Randomized Controlled Trial to Assess the Effectiveness of Aquatic Specific Physiotherapy in the Improvement of Balance and Gait.', 'orgStudyIdInfo': {'id': 'ECA-FALMI-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Aquatic Therapy (EAT)', 'description': 'Aquatic physiotherapy treatment at time 1 (week 1)', 'interventionNames': ['Procedure: aquatic physiotherapy']}, {'type': 'OTHER', 'label': 'Late Aquatic Therapy (LAT)', 'description': 'Control for Group 1 for the 5 first weeks of Group 1 treatment. Aquatic physiotherapy treatment at time 2 (week 6).', 'interventionNames': ['Procedure: aquatic physiotherapy']}], 'interventions': [{'name': 'aquatic physiotherapy', 'type': 'PROCEDURE', 'otherNames': ['hydrotherapy'], 'description': 'specific aquatic physiotherapy 3 times a week, for 6 weeks, including feet balance exercises (Rating of Perceived Effort (RPE)), slow walking in all directions, walking with obstacles, Ai Chi, exercises of muscular strength. Each session duration is of 40 minutes.', 'armGroupLabels': ['Early Aquatic Therapy (EAT)', 'Late Aquatic Therapy (LAT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45071', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Nacional de Parapléjicos', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'overallOfficials': [{'name': 'Inés Martínez-Galán, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Castilla-La Mancha'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}