Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-03 @ 8:46 AM
Study NCT ID:
NCT02878304
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Structural and functional connectivity measures; functional Magnetic Resonance Imaging', 'timeFrame': 'From 4 weeks to 6 months'}, {'measure': 'Change in NeuroFlexor(C) measures', 'timeFrame': 'From 4 weeks to 3 and 6 months', 'description': 'Quantitative measures of the neural and biomechanical components of the force resisting passive movement of ther wrist'}, {'measure': 'Change in modulation of gripforce: Visuomotor grip force tracking task', 'timeFrame': 'From 4 weeks to 3 and 6 months'}, {'measure': 'Change in Action Research Arm Test, ARAT', 'timeFrame': 'From 4 weeks to 3 and 6 months'}, {'measure': 'Change in Strength-Dexterity test', 'timeFrame': 'From 4 weeks to 3 and 6 months', 'description': 'Dexterous ability/quantification of precision in finger movements'}, {'measure': 'Change in grip force', 'timeFrame': 'From 4 weeks to 3 and 6 months', 'description': 'Dynamometry'}, {'measure': 'Change in Assisting Hand Assessment, AHA', 'timeFrame': 'From 4 weeks to 3 and 6 months', 'description': 'Measures of the spontaneous use of the more affected hand in specific bimanual activities'}, {'measure': 'Change in Box and Block Task, BBT', 'timeFrame': 'From 4 weeks to 3 and 6 months'}], 'primaryOutcomes': [{'measure': 'Change in Fugl-Meyer Assessment for Upper Extremity', 'timeFrame': 'From 4 weeks to 3 and six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prognosis', 'Hand function', 'Rehabilitation', 'Spasticity', 'MRI'], 'conditions': ['Stroke', 'Hemiparesis']}, 'referencesModule': {'references': [{'pmid': '34400568', 'type': 'DERIVED', 'citation': 'Plantin J, Verneau M, Godbolt AK, Pennati GV, Laurencikas E, Johansson B, Krumlinde-Sundholm L, Baron JC, Borg J, Lindberg PG. Recovery and Prediction of Bimanual Hand Use After Stroke. Neurology. 2021 Aug 17;97(7):e706-e719. doi: 10.1212/WNL.0000000000012366. Epub 2021 Jun 14.'}, {'pmid': '33493822', 'type': 'DERIVED', 'citation': 'Hybbinette H, Ostberg P, Schalling E. Intra- and Interjudge Reliability of the Apraxia of Speech Rating Scale in Early Stroke Patients. J Commun Disord. 2021 Jan-Feb;89:106076. doi: 10.1016/j.jcomdis.2020.106076. Epub 2021 Jan 6.'}, {'pmid': '31906829', 'type': 'DERIVED', 'citation': 'Pennati GV, Plantin J, Carment L, Roca P, Baron JC, Pavlova E, Borg J, Lindberg PG. Recovery and Prediction of Dynamic Precision Grip Force Control After Stroke. Stroke. 2020 Mar;51(3):944-951. doi: 10.1161/STROKEAHA.119.026205. Epub 2020 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures.', 'detailedDescription': 'Almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. Improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation.\n\n100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. The imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional MRI for structural and functional connectivity analyses, respectively. Clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function.\n\nProHand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are recruited at entry to a specialized sub-acute rehabilitation unit after first time stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first ever stroke and clinically diagnosed arm paresis\n\nExclusion Criteria:\n\n* incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.'}, 'identificationModule': {'nctId': 'NCT02878304', 'acronym': 'ProHand', 'briefTitle': 'Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study', 'organization': {'class': 'OTHER', 'fullName': 'Danderyd Hospital'}, 'officialTitle': 'Recovery of Hand Function After Stroke- a Longitudinal Study Using Novel Methods to Quantify Hand Function and Connectivity in Brain Networks', 'orgStudyIdInfo': {'id': 'PROHAND_001'}}, 'contactsLocationsModule': {'locations': [{'zip': '18288', 'city': 'Stockholm', 'state': 'Danderyd', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jeanette Plantin, PhD stud.', 'role': 'CONTACT', 'email': 'jeanette.plantin@ki.se', 'phone': '00467969495796'}], 'facility': 'Danderyd University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Jeanette AM Plantin, PhD student', 'role': 'CONTACT', 'email': 'jeanette.plantin@ki.se', 'phone': '0046709169232'}, {'name': 'Påvel G Lindberg, Ass. Prof.', 'role': 'CONTACT', 'email': 'pavel.lindberg@ki.se', 'phone': '0033140789244'}], 'overallOfficials': [{'name': 'Jörgen Borg, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Rehabilitation Medicine, Danderyd University Hospital, Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danderyd Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}