Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 8:17 AM
Study NCT ID:
NCT04252092
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D012678', 'term': 'Sensation Disorders'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cansu5309@gmail.com', 'phone': '+905378405948', 'title': 'PT,Cansu Hayıroğlu', 'organization': 'Eksen Sağlık ve Rehabilitasyon'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 Months', 'description': 'No adverse effects has been found as this study is applied on the parts of the body that is not relevant to their vital signs.', 'eventGroups': [{'id': 'EG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment Of Joint Position Sense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': "Joint position sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient's eyes will be closed. One of the foot on the hemiplegic side of the patient will be brought to a certain position and the patient will be asked to bring the other extremity to a similar position.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.", 'unitOfMeasure': 'correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assesment of Joint Passive Motion Sense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '8.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': "Joint passive motion sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient's eyes will be closed. One of the patient's big toe in hemiplegic their side will be held on either side and moved up or down. During this time, the patient will be asked to indicate the direction of the movement.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.", 'unitOfMeasure': 'correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Vibration Sense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '6.6', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': 'Vibration sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. It is evaluated with a vibrating diapason. While the eyes are closed, the diapason will be placed on the tip of the big toe of the hemiplegic foot, the patient will be asked if the vibration is felt or not. If it is felt, this time the patient will be asked to indicate the moment when the vibration ends. Thus, the time it detects the vibration is determined. This period is about 20 seconds in normal youth. As the age progresses, it should be remembered that vibration time is shortened in lower extremities.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assesment of Deep Pain Sense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '66.7', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '13.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': 'Deep pain sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. If the Achilles tendon is squeezed or the muscles are severely suppressed, it is investigated whether or not the pain is felt. If pain is felt, the result will be counted as positive. The positive result is an unwanted result.', 'unitOfMeasure': 'percentage of positive results', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Two-point Discrimination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': 'Two-point discrimination sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The points of the blunt wig will be held against the hemiplegic sole of the foot at different distances from each other. Instruct the client to respond to each touch, by saying one point or two points. Eyes should be closed during the examination. When the patient feels two, it will be noted how far away in cm away from the wig.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Graphesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': 'Graphesthesia assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient will be asked to estimate a letter or number written the sole of the hemiplegic foot with a blunt object while the eyes are closed.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.', 'unitOfMeasure': 'correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Tactile Localization Sense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': 'Tactile localization sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. Patients will be stimulated on 10 different locations of the hemiplegic sole of the foot. They will be asked to localize the touch. The response will be recorded.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.', 'unitOfMeasure': 'correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Tactile Inattention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '60', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '20', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 3', 'description': 'Tactile inattention assessment will be applied to all subjects (30 patients) at the beginning and end of treatments.The patient will close his eyes. The right and the left half of the body will be needled at the same time. The patient with tactile inattention perceives only one of them which is counted as positive. The positive result is an unwanted result.', 'unitOfMeasure': 'percentage of positive results', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment Of Cognitive Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'OG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Mini-mental test will be applied to all subjects (30 patients) at the beginning of treatments. A mini-mental test will be performed to evaluate the patient's cognitive level. This test will be used because it evaluates orientation, recording memory, attention, and computation, remembering and language, orientation, praxis skills.\n\nIn the test consisting of 30 questions and 30 points, a total of ≥25 points were considered normal, 21-24 points Light, 10-20 points medium, and ≤9 serious cognitive disorders. Higher scores mean better outcome with 0 being minimum and 30 being maximum.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'FG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training\n\nSensory training: 15 session,20 minutes sensory training program'}, {'id': 'BG001', 'title': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation\n\nElectrical stimulation: 15 session,20 minutes electrical stimulation program'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.8', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '69.4', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '67.6', 'spread': '7.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-17', 'size': 114254, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-06T14:44', 'hasProtocol': False}, {'date': '2020-02-17', 'size': 293973, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-06T14:45', 'hasProtocol': False}, {'date': '2020-02-17', 'size': 351513, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-06T14:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2019-12-17', 'resultsFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-01-29', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-07', 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment Of Joint Position Sense', 'timeFrame': 'Baseline and Week 3', 'description': "Joint position sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient's eyes will be closed. One of the foot on the hemiplegic side of the patient will be brought to a certain position and the patient will be asked to bring the other extremity to a similar position.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum."}, {'measure': 'Assesment of Joint Passive Motion Sense', 'timeFrame': 'Baseline and Week 3', 'description': "Joint passive motion sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient's eyes will be closed. One of the patient's big toe in hemiplegic their side will be held on either side and moved up or down. During this time, the patient will be asked to indicate the direction of the movement.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum."}, {'measure': 'Assessment of Vibration Sense', 'timeFrame': 'Baseline and Week 3', 'description': 'Vibration sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. It is evaluated with a vibrating diapason. While the eyes are closed, the diapason will be placed on the tip of the big toe of the hemiplegic foot, the patient will be asked if the vibration is felt or not. If it is felt, this time the patient will be asked to indicate the moment when the vibration ends. Thus, the time it detects the vibration is determined. This period is about 20 seconds in normal youth. As the age progresses, it should be remembered that vibration time is shortened in lower extremities.'}, {'measure': 'Assesment of Deep Pain Sense', 'timeFrame': 'Baseline and Week 3', 'description': 'Deep pain sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. If the Achilles tendon is squeezed or the muscles are severely suppressed, it is investigated whether or not the pain is felt. If pain is felt, the result will be counted as positive. The positive result is an unwanted result.'}, {'measure': 'Assessment of Two-point Discrimination', 'timeFrame': 'Baseline and Week 3', 'description': 'Two-point discrimination sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The points of the blunt wig will be held against the hemiplegic sole of the foot at different distances from each other. Instruct the client to respond to each touch, by saying one point or two points. Eyes should be closed during the examination. When the patient feels two, it will be noted how far away in cm away from the wig.'}, {'measure': 'Assessment of Graphesthesia', 'timeFrame': 'Baseline and Week 3', 'description': 'Graphesthesia assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient will be asked to estimate a letter or number written the sole of the hemiplegic foot with a blunt object while the eyes are closed.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.'}, {'measure': 'Assessment of Tactile Localization Sense', 'timeFrame': 'Baseline and Week 3', 'description': 'Tactile localization sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. Patients will be stimulated on 10 different locations of the hemiplegic sole of the foot. They will be asked to localize the touch. The response will be recorded.\n\nIn the case of the correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.'}, {'measure': 'Assessment of Tactile Inattention', 'timeFrame': 'Baseline and Week 3', 'description': 'Tactile inattention assessment will be applied to all subjects (30 patients) at the beginning and end of treatments.The patient will close his eyes. The right and the left half of the body will be needled at the same time. The patient with tactile inattention perceives only one of them which is counted as positive. The positive result is an unwanted result.'}], 'secondaryOutcomes': [{'measure': 'Assessment Of Cognitive Level', 'timeFrame': 'Baseline', 'description': "Mini-mental test will be applied to all subjects (30 patients) at the beginning of treatments. A mini-mental test will be performed to evaluate the patient's cognitive level. This test will be used because it evaluates orientation, recording memory, attention, and computation, remembering and language, orientation, praxis skills.\n\nIn the test consisting of 30 questions and 30 points, a total of ≥25 points were considered normal, 21-24 points Light, 10-20 points medium, and ≤9 serious cognitive disorders. Higher scores mean better outcome with 0 being minimum and 30 being maximum."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrical stimulation', 'Sensory education', 'Sensory evaluation', 'Stroke', 'Proprioception'], 'conditions': ['Hemiplegia', 'Stroke, Acute', 'Sensory Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of the sole of foot sensory education and electrical stimulation on proprioceptive and cortical senses in patients with acute hemiplegia.', 'detailedDescription': "Hemiplegia is a syndrome characterized by disorders of motor and sensory functions, speech and mental abilities. Hemiplegia is a common neurological problem in the world and is the third most common cause of death.\n\nIn addition to motor loss in patients after stroke, sensory problems are accompanied and close to 60% of stroke patients experience sensory problems. In a limited number of studies in the literature, it is stated that sensory impairment in the lower extremity negatively affects standing, walking speed, balance during ambulation and symmetrical gait. At the same time, it has been proven that the sole of the foot sense plays an important role in the balance of sitting, standing up and performing independent daily living activities. After a stroke, sensory training increases functionality, patients with sensory training recover faster, mobility, balance and daily life activities become better, and daily life improvement is expressed. The purpose of sensory training is to maximize the patient's learning through the connection between environment and repetitive activities.\n\nThe aim of this study is to compare the effects of neurodevelopmental physiotherapy program combined with sensory training or electrical stimulation on the sole of the foot proprioceptive and cortical senses in individuals diagnosed with hemiplegia.\n\nThere is no study on how proprioceptive and cortical sensations will be affected in acute hemiplegic patients if sensory training and electrical stimulation are added to the classical treatment program. By finding and comparing the effects of active (sensory training) and passive treatment (electric stimulation) with this study, it was planned to propose an effective treatment protocol for developing the sole of the foot senses to the experts working in this field.\n\nAs a result, purpose of the study is to prevent inadequate sensory input in hemiplegic patients from adversely affecting quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating to the study in a voluntary basis\n* Patients with 50-80 years old\n* A stroke diagnosis by a neurologist\n* A stroke attack within 6 months\n* Minimum 18 points from Mini Mental Test\n* Medically stable\n\nExclusion Criteria:\n\n* Unstable condition\n* Other neurological or orthopaedic problems that will affect function other than stroke\n* Uncontrolled hypertension\n* Diabetic foot ulcers\n* Part/total foot amputation'}, 'identificationModule': {'nctId': 'NCT04252092', 'briefTitle': 'Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'Effects Of Sensory Training and Electrical Stimulation in Sole of The Foot on Proprioceptive and Cortical Sensations in Patients With Acute Hemiplegia', 'orgStudyIdInfo': {'id': 'i79zrwdy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensory Group', 'description': '15 patients who will be applied 15 sessions of sensory training', 'interventionNames': ['Other: Sensory training']}, {'type': 'EXPERIMENTAL', 'label': 'Electrical Stimulation Group', 'description': '15 patients who will be applied 15 sessions of electrical stimulation', 'interventionNames': ['Other: Electrical stimulation']}], 'interventions': [{'name': 'Sensory training', 'type': 'OTHER', 'description': '15 session,20 minutes sensory training program', 'armGroupLabels': ['Sensory Group']}, {'name': 'Electrical stimulation', 'type': 'OTHER', 'description': '15 session,20 minutes electrical stimulation program', 'armGroupLabels': ['Electrical Stimulation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Eksen Sağlık', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}