Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05084820
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2021-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke
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', 'interventionModelDescription': 'each participant will be requested to draw either number one or two from a box.number one refers to group A and number two refers to group B. Group A patients will receive conventional treatment of 40 minutes in total. group B is experimental group , patients will watch videos of 5 common motor tasks that implicit the usage of items to be used for action observation treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified barthal index', 'timeFrame': '40 minutes', 'description': 'The Modified Barthel Index score was used for practical evaluation in activities of daily living. The MBI comprises of 10 items, 6 out of 10 items scored from 0-2 points, 2 items scored from 0-3 points and other 2 items scored from 0-3 points, giving a highest total score of 20 points.'}, {'measure': 'Fugl-Meyer Assessment test', 'timeFrame': '40 minutes', 'description': 'Fugl-Meyer Assessment test for Upper extermity.to assess level of motor impairment and its recovery after treatment. The FMA-UE comprises of 7 times.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'action observation treatment'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '32608554', 'type': 'BACKGROUND', 'citation': 'Mao H, Li Y, Tang L, Chen Y, Ni J, Liu L, Shan C. Effects of mirror neuron system-based training on rehabilitation of stroke patients. Brain Behav. 2020 Aug;10(8):e01729. doi: 10.1002/brb3.1729. Epub 2020 Jul 1.'}, {'pmid': '32919473', 'type': 'BACKGROUND', 'citation': 'Keller J, Stetkarova I, Macri V, Kuhn S, Petioky J, Gualeni S, Simmons capital ES, CyrillicD, Arthanat S, Zilber P. Virtual reality-based treatment for regaining upper extremity function induces cortex grey matter changes in persons with acquired brain injury. J Neuroeng Rehabil. 2020 Sep 12;17(1):127. doi: 10.1186/s12984-020-00754-7.'}, {'pmid': '31198470', 'type': 'BACKGROUND', 'citation': 'Keci A, Tani K, Xhema J. Role of Rehabilitation in Neural Plasticity. Open Access Maced J Med Sci. 2019 May 14;7(9):1540-1547. doi: 10.3889/oamjms.2019.295. eCollection 2019 May 15.'}, {'pmid': '30147952', 'type': 'BACKGROUND', 'citation': 'Habibi-Koolaee M, Shahmoradi L, Niakan Kalhori SR, Ghannadan H, Younesi E. Prevalence of Stroke Risk Factors and Their Distribution Based on Stroke Subtypes in Gorgan: A Retrospective Hospital-Based Study-2015-2016. Neurol Res Int. 2018 Jul 26;2018:2709654. doi: 10.1155/2018/2709654. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effects of action observation treatment on motor functions in upper limb of patients with chronic stroke', 'detailedDescription': 'Stroke is one of the major cause of death in Pakistan and also a prime source of disability in older adults.Mirror neuron system depends on motor regions, and its dominant aspect is that,it is activated for implementation of motor activity and also for its observation. This "dual activation" characteristic of mirror neuron helps in improving the observation and execution of different actions.\n\naim of this study is to determine the effects of action observation treatment on motor function in upper limb of patients with chronic stroke.\n\nAn RCT will be conducted on 14 chronic stroke patients from Omar Hospital and Riphah Rehabilitation Centre Lahore. Patients will be randomly allocated into control group (n=7) and Experimental group (n=7) by lottery method. Control group will be given only conventional treatment that included stretching, strengthening, pinching, gripping, reaching and grasping exercises, while Experimental group received conventional treatment and action observation treatment 3 days/ week for 4 weeks. Treatment outcomes will be assessed on Modified Barthel Index and Fugl-Meyer Assessment for upper extremity (FMA-UE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Stroke patients (with more than 6 months- 4 years) illness\n* Patients that were able to communicate and comprehend oral instructions\n* Patients with Mini Mental State Examination (MMSE) score more than 24\n\nExclusion Criteria:\n\n* Patients having psychiatric histories.\n* Visual and hearing impaired patients\n* Patients with speech impairment\n* Patients with arthritic deformities in upper limb (with or without using assistive device)\n* Patients with diagnosed mental illness.'}, 'identificationModule': {'nctId': 'NCT05084820', 'briefTitle': 'Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke', 'orgStudyIdInfo': {'id': 'REC/Lhr/20/0213 Hira Rehman'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Action observation treatment', 'description': 'Action observation treatment', 'interventionNames': ['Combination Product: Action observation treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional treatment', 'description': 'conventional treatment', 'interventionNames': ['Combination Product: conventional treatment']}], 'interventions': [{'name': 'Action observation treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants will watch 5 videos of motor tasks; each video is of 30 sec and watch for 4 times (i.e. for 2 minutes). Then patient will execute the motor act, soon after the observation with an affected limb for 2 minutes, with total rest time of 5 minutes for this treatment. Conventional treatment of muscle stretching, strengthening and ROM exercises will be given for 15 minutes including rest. Total treatment time is 40 minutes.', 'armGroupLabels': ['Action observation treatment']}, {'name': 'conventional treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'conventional treatment of 40 minutes in total will be performed including Stretching (for 8-10 sec with set of 5 repetitions/ session on each side for 3 minutes total with rest), strengthening (weighted bicep curls, side arm raise and open arm movement exercises with set of 5 repetitions/ session for 9 minutes total with rest), Range of motion exercises active and passive with set of 5 repetitions/ session for 3 minutes total with rest and gripping,reaching, grasping exercises (on each side for total 25 minutes including rest) with assistance of physiotherapist', 'armGroupLabels': ['conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Fedral', 'country': 'Pakistan', 'facility': 'Riphah international university', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'zeest hashmi, MS NMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}