Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT07204067
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mirror Therapy for Hand Function Recovery in Acute 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment (2 arms)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Spasticity (Modified Ashworth Scale, 0-4)', 'timeFrame': '6 months', 'description': 'Change baseline→week 1; lower = less spasticity.'}, {'measure': 'Range of Motion (Goniometric AROM at shoulder, elbow, wrist, finger joints; degrees)', 'timeFrame': '6 months', 'description': 'Change baseline→week 1; higher = improved ROM.'}], 'primaryOutcomes': [{'measure': 'Upper-Limb Function (ARAT total score, 0-57)', 'timeFrame': '6 Months', 'description': 'Change from baseline to end of week 1; higher scores = better function.'}], 'secondaryOutcomes': [{'measure': 'Motor Function (Motor Assessment Scale - relevant upper-limb items, 0-6 per item)', 'timeFrame': '6months', 'description': 'Change baseline→week 1; higher = better.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mirror Therapy Acute Stroke'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial to determine whether mirror therapy (MT), added to conventional physiotherapy, improves upper-limb motor recovery, hand function, spasticity, and range of motion (ROM) in acute stroke compared with conventional physiotherapy alone. Outcomes include ARAT, Motor Assessment Scale, Modified Ashworth Scale, and goniometric ROM.', 'detailedDescription': 'Stroke causes significant upper-limb impairment in the acute stage; early, targeted rehabilitation leverages heightened neuroplasticity. Mirror therapy uses a mid-sagittal mirror to reflect movements of the non-paretic limb, creating the illusion of normal movement in the paretic limb, recruiting mirror neuron circuits and facilitating motor relearning. Prior work suggests MT can improve fine and gross motor skills, reduce spasticity, and increase active ROM. This trial operationalizes a pragmatic MT protocol integrated with standard inpatient/outpatient physiotherapy in acute stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 40-55 years\n* Acute ischemic or hemorrhagic stroke within the last 1 month\n* Unilateral hemiparesis/hemiplegia\n* Medically stable and cleared for rehabilitation\n* Able to follow verbal instructions; MMSE ≥ 24\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Recurrent stroke or bilateral involvement\n* Severe cognitive impairment (MMSE \\< 24)\n* Visual field deficits, unilateral neglect, or severe aphasia interfering with MT\n* Other neurological disorders (e.g., Parkinson's, MS)\n* Orthopedic conditions affecting upper limb/trunk\n* Uncontrolled cardio-respiratory disease limiting exercise\n* Severe spasticity (MAS ≥ 3) in affected limb\n* Concurrent enrollment in other interventional trials\n* Inability/refusal to consent"}, 'identificationModule': {'nctId': 'NCT07204067', 'acronym': 'Stroke', 'briefTitle': 'Mirror Therapy for Hand Function Recovery in Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effectiveness of Mirror Therapy in Improving Motor Recovery and Hand Function in Patients With Acute Stroke A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RIPHAH-REC Sapna Kursheed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror Therapy + Conventional Physiotherapy', 'description': 'Experimental: Mirror Therapy + Conventional Physiotherapy\n\nDevice/Procedure: Mirror Therapy (20 min/session) + immediate Conventional Physiotherapy (20 min/session)\n\nSchedule: 2 sessions/week for 1 week (total: 2 sessions)\n\nMT Procedure: Mirror (box or plain) placed along mid-sagittal plane reflecting the non-paretic limb while hiding the paretic limb. Participants perform bilateral symmetrical movements focusing on the mirror image (e.g., wrist flex/ext, finger flex/ext, elbow flex/ext, reaching \\& grasping).\n\nConventional Content (immediately after MT): strengthening \\& functional task practice (e.g., reaching/transfers), plus targeted hand training: theraputty squeezes, finger extension with rubber band, towel wringing, lifting small objects, reaching overhead/side-to-side with weight, weighted ball toss/catch.', 'interventionNames': ['Behavioral: Mirror Therapy Conventional Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Physiotherapy Only', 'description': 'Procedure: Conventional Physiotherapy (20 min/session), no mirror. Same schedule and exercise menu as above without visual mirror feedback.\n\nNotes: The proposal specifies 1 week duration with 2 sessions/week, 20 min each; centers may extend to clinically standard dosage via protocol amendment if needed.', 'interventionNames': ['Behavioral: Mirror Therapy Conventional Physiotherapy']}], 'interventions': [{'name': 'Mirror Therapy Conventional Physiotherapy', 'type': 'BEHAVIORAL', 'otherNames': ['intervention for stroke'], 'description': 'Experimental: Mirror Therapy + Conventional Physiotherapy Mirror therapy performed 20 min/session, 2 sessions/week for 1 week. A mirror is placed midsagittal, reflecting the non-paretic limb while hiding the paretic limb. Patients perform bilateral movements (wrist, finger, elbow flex/extension; reaching/grasping) while focusing on the mirror image. This is followed by 20 min of conventional physiotherapy, including strengthening, functional tasks, theraputty squeezes, finger extension with rubber band, towel wringing, lifting small objects, overhead reaching, and ball toss.\n\nActive Comparator: Conventional Physiotherapy Only Conventional physiotherapy 20 min/session, 2 sessions/week for 1 week. Exercises include upper limb strengthening, functional task practice, theraputty squeezes, finger extension with rubber band, towel wringing, lifting small objects, overhead reaching, and ball toss.', 'armGroupLabels': ['Conventional Physiotherapy Only', 'Mirror Therapy + Conventional Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23060', 'city': 'Malakand', 'state': 'KPK', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Dr.Nadeem Ahmad, MS', 'role': 'CONTACT', 'email': 'n.ahmad@riphah.edu.pk', 'phone': '03451915105'}, {'name': 'Dr.Nadeem Ahmad, MS', 'role': 'CONTACT', 'email': 'drnadeem765@gmail.com', 'phone': '03028367237'}], 'facility': 'Riphah international University Malakand Campus', 'geoPoint': {'lat': 34.56561, 'lon': 71.93043}}], 'centralContacts': [{'name': 'Dr.Nadeem Ahmad, MS', 'role': 'CONTACT', 'email': 'n.ahmad@riphah.edu.pk', 'phone': '03451915105'}, {'name': 'Dr.Nadeem Ahmad, MS', 'role': 'CONTACT', 'email': 'drnadeem765@gmail.com', 'phone': '03028367237'}], 'overallOfficials': [{'name': 'Dr.Nadeem Ahmad, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}