Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 11:53 PM
Study NCT ID:
NCT05196633
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2021-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spasticity grade change', 'timeFrame': 'Change from baseline Modified Ashworth Scale at 14 days', 'description': 'The Modified Ashworth Scale (MAS)'}], 'secondaryOutcomes': [{'measure': 'Range of motion change', 'timeFrame': 'Change from baseline Passive Range of Motion at 14 days', 'description': 'passive range of motion (PROM) parameter measured through a hand-held goniometer'}, {'measure': 'Pain intensity change', 'timeFrame': 'Change from baseline Visual Analogue Scale at 14 days', 'description': 'Visual Analogue Scale (VAS) through a vertical 10-cm line (0 - starting pain-free to 10 - the worst imaginable pain). The higher the score means a worse outcome.'}, {'measure': 'Stabilometric outcomes change', 'timeFrame': 'Change from baseline Prokin system parameters at 14 days', 'description': 'Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm\\^2) and dynamic balance (mm\\^2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'spasticity', 'balance trainer', 'balance impairment', 'neurologic rehabilitation'], 'conditions': ['Stroke, Ischemic', 'Stroke Hemorrhagic', 'Spasticity as Sequela of Stroke', 'Spastic Gait', 'Balance; Distorted']}, 'descriptionModule': {'briefSummary': 'This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.', 'detailedDescription': 'The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect.\n\nThe stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs.\n\nAdditional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;\n* no history of previous stroke;\n* lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);\n* pain intensity measured on Visual Analogue Scale (VAS) ≥1;\n* ability to stand unassisted in upright position for 30 seconds;\n* no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale\n* adult patients (\\>18 years old)\n\nExclusion Criteria:\n\n* other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;\n* myopathies;\n* severe cognitive impairment, severe aphasia or inability to understand instructions;\n* severe spasticity;\n* visual field conditions or hemineglect;\n* patients unable to undergo follow-up evaluation and excluded from the final analysis;\n* anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.'}, 'identificationModule': {'nctId': 'NCT05196633', 'briefTitle': 'Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:', 'organization': {'class': 'OTHER', 'fullName': 'Carol Davila University of Medicine and Pharmacy'}, 'officialTitle': 'Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2090/C.E.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional physiotherapy, visual feedback training, rESWT', 'description': 'conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks)', 'interventionNames': ['Other: radial extracorporeal shock wave therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Conventional physiotherapy, visual feedback training, sham rESWT', 'description': 'conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks)', 'interventionNames': ['Other: sham radial extracorporeal shock wave therapy']}], 'interventions': [{'name': 'radial extracorporeal shock wave therapy', 'type': 'OTHER', 'description': 'rESWT (Endopuls 811; Enraf Nonius B.V. Va-reseweg 127, 3047 AT Rotterdam MedTech, Wessling, Germany) will be applied on the myotendinous junction of both the gastrocnemius and the soleus muscles in post-stroke spasticity patients. 2000 shots will be applied on the gastrocnemius and soleus myotendinous junction with a frequency of 10 Hz and energy density of 60 mJ (1 bar) within tolerable pain limits.', 'armGroupLabels': ['Conventional physiotherapy, visual feedback training, rESWT']}, {'name': 'sham radial extracorporeal shock wave therapy', 'type': 'OTHER', 'description': 'The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.', 'armGroupLabels': ['Conventional physiotherapy, visual feedback training, sham rESWT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '011461', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Elias University Emergency Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Mihai Berteanu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carol Davila University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emanuela Elena Mihai', 'investigatorAffiliation': 'Carol Davila University of Medicine and Pharmacy'}}}}