Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-04-22 @ 2:56 PM
Study NCT ID:
NCT02232295
Status:
COMPLETED
Last Update Posted:
2014-09-05
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-04', 'studyFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2014-09-04', 'lastUpdatePostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper limb motor functions', 'timeFrame': 'six weeks', 'description': 'Primary Outcome measures: FMA Scale and CAHAI scale\n\nFMA Scale:\n\nIt is a stroke specific, performance based impairment index. This scale includes items related to movements of the shoulder, elbow, forearm, wrist, and hand in the upper extremity, as well as the hip, knee, and ankle in the lower extremity. For the present study, only the upper extremity was measured.The total score on the upper extremity part of the FMA ranged from 0 (hemiplegia) to a maximum of 66 points (normal motor performance). The scale was measured at baseline and post intervention.\n\nCAHAI Scale:\n\nThe purpose of this measure is to evaluate the functional ability of the hemiplegic arm and hand to perform tasks. It is designed to encourage the bilateral hand to complete the task.Each task was demonstrated once before performance, then the Score was evaluated of the affected upper extremity using the 7 point activity scale from total assistance (1) to complete'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '6 weeks', 'description': 'Secondary outcome measure:\n\nSS-QOL (Stroke Specific- Quality of life) Scale It is a self report scale containing 49 items in 12 domains. It is intended to provide an assessment of health related quality of life specific to patients with stroke. Scale domains and items were derived from a series of interviews with patients.The scale was measured at baseline and post intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Upper extremity, motor imagery, mirror therapy'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of the Study to evaluate the effect of Graded motor imagery on upper limb motor functions and quality of life in patients with stroke that was conducted in two centers in india. The primary outcome measures were upper limb motor functions at 6 weeks and secondary outcome measure was quality of life at 6 weeks.\n\nResearch Hypothesis: There would be significant effect of GMI on Upper limb motor functions and quality of life in patients with stroke.', 'detailedDescription': 'Graded Motor Imagery (GMI) is essentially a brain based treatment, targeting the activation of different brain regions in a graded manner. GMI is a three stage treatment programme comprising of Left Right discrimination training, Explicit Motor imagery and Mirror therapy.\n\nIn this Study, GMI approach is applied on the patients with Stroke to enhance their Upper limb motor functions and Quality of life.\n\nConventional treatment:\n\nPatients of group A and group B had received conventional treatment for 6 weeks. Conventional treatment consists of Task oriented upper extremity functional exercises. Components of Task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities. It was performed five days a week for six weeks of one hour duration.\n\nGraded Motor Imagery:\n\nPatients of group A had received GMI programme with conventional treatment for 6 weeks. It is a three stage process, was performed five days a week for six weeks of one hour duration. It comprises of:\n\n* Left Right discrimination training (Implicit Motor Imagery) - 2 weeks\n* Explicit Motor Imagery (Imagined movements) - 2 weeks\n* Mirror Therapy - 2 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age (between 45 to 65 years)\n* Individuals who experienced one episode of stroke only.\n* Both males and females were included in the study\n* Both ischemic \\& haemorrhagic stroke individuals were included in the study\n* Duration of stroke between 1 to 6 months\n* Mini mental status examination (MMSE) (score \\> 23)\n* Patients with Brunnstrom stage 1 \\& 2\n\nExclusion Criteria:\n\n* Individuals having any musculoskeletal disorders\n* Individuals having any neurological disorder other than stroke\n* Individuals with any visual impairment\n* Individuals having any systemic disease\n* Non cooperative patients\n* Patients suffering from psychological problems'}, 'identificationModule': {'nctId': 'NCT02232295', 'briefTitle': 'A Clinical Trial to Study the Effect of Imagined Progressive Movements in Patients With Paralysis of One Side of the Body.', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'To Study the Effect of Graded Motor Imagery on Upper Limb Motor Functions and Quality of Life in Patients With Stroke', 'orgStudyIdInfo': {'id': 'M44-124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional group', 'description': 'Conventional group consist of Upper extremity task oriented functional exercises. Components of Task oriented training include weight bearing, supportive reactions, and reaching, grasping, holding and release activities.', 'interventionNames': ['Device: Mirror Box']}, {'type': 'EXPERIMENTAL', 'label': 'Graded Motor imagery group and Conventional group', 'description': 'Graded Motor imagery is a three stage process, was performed five days a week for six weeks of one hour duration. It comprises of:\n\n* Left Right discrimination training (Implicit Motor Imagery) - 2 weeks\n* Explicit Motor Imagery (Imagined movements) - 2 weeks\n* Mirror Therapy - 2 weeks', 'interventionNames': ['Device: Recognise [TM]']}], 'interventions': [{'name': 'Recognise [TM]', 'type': 'DEVICE', 'otherNames': ['Online Recognise software by the NOI group, Australia'], 'description': 'Recognise accurately measures to identify left and right body parts and movements, and to train left/right discrimination as part of a comprehensive GMI rehabilitation process.', 'armGroupLabels': ['Graded Motor imagery group and Conventional group']}, {'name': 'Mirror Box', 'type': 'DEVICE', 'description': 'A resource used for many pain and disability states of the hands and feet.', 'armGroupLabels': ['Conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133207', 'city': 'Ambāla', 'state': 'Haryana', 'country': 'India', 'facility': 'Maharishi Markandeshwar institute of Physiotherapy and rehabilitation, MMU, Mullana', 'geoPoint': {'lat': 30.36099, 'lon': 76.79782}}], 'overallOfficials': [{'name': 'Manisha Uttam, Masters in Physiotherapy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi Markandeshwar University, Mullana-Ambala'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Manisha Uttam', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}