Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:30 AM
Study NCT ID:
NCT07425158
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences in Treatment Characteristics and Patient and Therapist Satisfaction Between Robot Assisted Therapy and Conventional Occupational Therapy Among Individuals Post Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observation', 'timeFrame': '30 min', 'description': 'The number of repetitions and compensations will be counted by observation'}], 'secondaryOutcomes': [{'measure': 'VAS', 'timeFrame': '1min', 'description': 'The Visual Analogue Scale (VAS) is a common scale for estimating pain level from one to ten.'}, {'measure': 'Questionnaire', 'timeFrame': '5 min', 'description': 'A subjective satisfaction questionnaire regarding the treatment will be administered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robot Assisted Therapy', 'Upper Extremity Paresis'], 'conditions': ['CVA (Cerebrovascular Accident)', 'Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the differences in treatment characteristics and patient and therapist satisfaction, between Robot Assisted Therapy (RAT) and Conventional Occupational Therapy (COT) single session in individuals post stroke.', 'detailedDescription': 'Method and research procedure: The study will include 30 sub-acute post stroke patients, aged 18-85, with severe motor impairment in the upper limb and with normal-mild cognitive ability, hospitalized at the Loewenstein Rehabilitation Hospital. Each subject will receive two 30-min treatment sessions, one Conventional Occupational Therapy (COT) and one Robot Assisted Therapy (RAT). Before and during each session, the Visual Analogue Scale (VAS) for reporting the level of pain will be administered. The number of repetitions and compensations will be counted by observation. After each session, a subjective satisfaction questionnaire regarding the treatment will be administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 85 year old following stroke (first-ever stroke).\n2. Individuals in the sub-acute phase (up to three months)\n3. Intact cognitive function (score \\> 21 points on the Mini Mental State Examination)\n4. Sever weakness of the affected upper limb (score 5-20 points on the FMA)\n5. Understanding and reading Hebrew\n6. Normal or corrected eyesight.\n7. Subjects were at least in one session of RAT and one session of COT\n\nExclusion Criteria:\n\n1. Neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restrict upper limb function.\n2. High muscle tone (score \\> 4 in Modified Ashworth Scale)\n3. Apraxia (score \\<68 in De Renzi Apraxia Test)\n4. Severe Sensory impairment.'}, 'identificationModule': {'nctId': 'NCT07425158', 'briefTitle': 'Differences in Treatment Characteristics and Patient and Therapist Satisfaction Between Robot Assisted Therapy and Conventional Occupational Therapy Among Individuals Post Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Loewenstein Hospital'}, 'officialTitle': 'Differences in Treatment Characteristics and Patient and Therapist Satisfaction Between Robot Assisted Therapy and Conventional Occupational Therapy Among Individuals Post Stroke', 'orgStudyIdInfo': {'id': '0020-20-LOE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Therapy', 'description': 'Each subject will receive two 30-min treatment sessions, one Robot Assisted Therapy and one Conventional Occupational Therapy.', 'interventionNames': ['Other: Robot Assisted Therapy (RAT)']}], 'interventions': [{'name': 'Robot Assisted Therapy (RAT)', 'type': 'OTHER', 'otherNames': ['Conventional occupational therapy (COT)'], 'description': 'Robot Assisted Therapy (RAT): 30-min treatment session of active- assisted movements of shoulder and elbow, using a robotic arm and a computer screen, provides different exercises according to the motor ability of the patient. The robot provides proximal upper limb training in a three-dimensional (3D) environment. The occupational therapist will be planning the treatment by determining the range of motion, the amount of help and support and the level of difficulty of the game.\n\nConventional occupational therapy (COT): 30-min treatment session of active- assisted movements of the shoulder and elbow, using conventional facilities and devices. Treatment includes passive range of motion exercises and active- assistive exercises. The level of support and help will be determined by the occupational therapist.', 'armGroupLabels': ['Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Raanana', 'country': 'Israel', 'facility': 'Loewenstein', 'geoPoint': {'lat': 32.1836, 'lon': 34.87386}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'linor kennet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tel Aviv University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Linor Kennet', 'investigatorFullName': 'linor kennet', 'investigatorAffiliation': 'Loewenstein Hospital'}}}}