Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2026-04-09 @ 11:26 PM
Study NCT ID:
NCT07029061
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2025-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)', 'timeFrame': 'Baseline and post 4-week intervention', 'description': 'Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), a validated stroke-specific scale. The FMA-UE ranges from 0 to 66, where higher scores indicate better motor and sensory function.'}], 'secondaryOutcomes': [{'measure': 'Change in trunk function measured by the Trunk Control Test (TCT)', 'timeFrame': 'Baseline and after 4-week intervention', 'description': 'Change in trunk function measured by the Trunk Control Test (TCT), which assesses four functional movements. The TCT ranges from 0 to 100, where higher scores indicate better trunk control and functional ability.'}, {'measure': 'Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)', 'timeFrame': 'Baseline and after 4-week intervention', 'description': 'Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest), which ranges from 0 to 28. Higher scores indicate better dynamic balance.'}, {'measure': 'Change in hand strength (flexion and extension) measured using the AMADEO robotic system.', 'timeFrame': 'Baseline and after 4-week intervention', 'description': 'Change in hand strength (flexion and extension) measured using the AMADEO robotic system. Strength will be recorded in Newtons (N). Higher values indicate greater muscle strength.'}, {'measure': 'Change in range of motion (ROM) of the shoulder and fingers measured using the AMADEO robotic system.', 'timeFrame': 'Baseline and after 4-week intervention', 'description': 'Change in range of motion (ROM) of the shoulder and fingers measured using the AMADEO robotic system. ROM will be recorded in degrees (°). Higher values indicate better joint mobility.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical Therapy', 'Air splints', 'Stroke', 'Upper Limb', 'Sensorimotor impairments'], 'conditions': ['Stroke Sequelae']}, 'descriptionModule': {'briefSummary': 'Objective: Sensory impairment in the affected upper limb occurs in approximately 50% of post-stroke patients and negatively impacts functional capacity and quality of life. This pilot study aims to evaluate whether the standardized use of pneumatic (air) splints, as part of a neurodevelopmental treatment approach, will have a positive effect on sensorimotor deficits in the hemiplegic upper limb of post-stroke patients.\n\nDesign: Pilot randomized, single-blind clinical trial.\n\nSetting: Brain injury rehabilitation facility.\n\nParticipants: Twenty adults in the subacute phase after stroke will be randomized into two groups. The experimental group (n = 10) will receive air splint therapy combined with physiotherapy (45 minutes per session, twice per week for 4 weeks). The control group (n = 10) will receive only physiotherapy with the same duration and frequency. Sensorimotor outcomes will be assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), and finger flexor/extensor strength will be measured using the Amadeo robotic system. Assessments will be conducted before and after the intervention.\n\nConclusions: The addition of air splints to physiotherapy may enhance exteroceptive and proprioceptive sensitivity in adults recovering from stroke during the subacute phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke at least 2 months earlier\n* Mild/moderate hypertonia (Ashworth ≤3)\n* Proprioceptive and exteroceptive deficits\n* Trunk stability score between 8-23 (TCT)\n\nExclusion Criteria:\n\n* Non-vascular etiology\n* Clinical instability\n* Skin lesions or deformities\n* Botulinum toxin in last 3 months\n* Cognitive/communication limitations\n* Maximum TCT score (23) at baseline'}, 'identificationModule': {'nctId': 'NCT07029061', 'briefTitle': 'Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient', 'organization': {'class': 'OTHER', 'fullName': 'Alfonso X El Sabio University'}, 'officialTitle': 'Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient: A Pilot Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Universidad Alfonso X El Sabio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device', 'interventionNames': ['Device: Air splints']}, {'type': 'NO_INTERVENTION', 'label': 'Physiotherapy alone following neurodevelopmental approach'}], 'interventions': [{'name': 'Air splints', 'type': 'DEVICE', 'description': 'Application of CPPS (Urias splints) + physiotherapy', 'armGroupLabels': ['Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Alicia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alfonso X El Sabio University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Beata María Ana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist (PhD)', 'investigatorFullName': 'Alicia Hernando Rosado', 'investigatorAffiliation': 'Alfonso X El Sabio University'}}}}