Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT03468504
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mirror Therapy and Treadmill Training for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}, {'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-12', 'size': 534763, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-09T06:14', 'hasProtocol': True}, {'date': '2014-12-12', 'size': 438802, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-09T06:15', 'hasProtocol': False}, {'date': '2014-12-12', 'size': 524269, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-03-09T06:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Experimental Group saw mirror image of non-affected limb in mirror while walking on treadmill.\n\nPlacebo Group saw no refection of the non-affected limb due to positioning of mirror while walking on treadmill.\n\nOutcome assessor was blinded to treatment allocation. They evaluated participants in separate lab and was asked not to discuss the treatment given to patients. Even if the patient mentioned the trials they would discuss the fact that they were using Mirrors and Treadmill.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot Randomised Placebo Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-03-15', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ten Metre Walk Test', 'timeFrame': '5 mins.', 'description': 'Walking velocity measure. Lower times indicate an increased walking velocity.'}, {'measure': 'Six Minute Walk Test', 'timeFrame': '10 mins', 'description': 'Walking endurance measure. Larger distance indicates an improved walking endurance ability.'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale', 'timeFrame': '10 minutes', 'description': 'Muscle tone measure. Range 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension).'}, {'measure': 'Fugl-Meyer Assessment-Lower extremity', 'timeFrame': '10 mins', 'description': 'Motor function outcome. Range 0 (Unable to do any functional Task) to 34 (Fully Independent in Functional Lower Extremity Tasks).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.', 'detailedDescription': 'The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis.\n* Ambulatory with/without walking aid.\n* Discharged from formal rehabilitation.\n* A Mini Mental State Examination \\>/= 24.\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Any additional illness that may prevent treadmill walking\n* A Mini Mental State Examination \\< 24.'}, 'identificationModule': {'nctId': 'NCT03468504', 'briefTitle': 'Mirror Therapy and Treadmill Training for Patients With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Technology, Sligo'}, 'officialTitle': 'Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'ITSligo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror Therapy & Treadmill Training', 'description': 'Mirror Therapy: Participants view a mirror reflection of their non-affected limb which is placed in their mid-sagittal plane for 30 mins per day, 3 days per week, for four weeks.\n\nTreadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.', 'interventionNames': ['Device: Mirror Therapy', 'Device: Treadmill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Mirror & Treadmill Training', 'description': 'Placebo Mirror Therapy: Participants view a mirror which is placed forward/ahead of them in their mid-sagittal plane, and cannot see a reflection of any lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.\n\nTreadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.', 'interventionNames': ['Device: Placebo Mirror Therapy', 'Device: Treadmill']}], 'interventions': [{'name': 'Mirror Therapy', 'type': 'DEVICE', 'otherNames': ['Mirror Designed by IT Sligo.'], 'description': 'Participants view the reflective side of a simple mirror which is placed in their mid-sagittal plane to view a mirror reflection of their non-affected limb for 30 mins per day, 3 days per week, for four weeks.', 'armGroupLabels': ['Mirror Therapy & Treadmill Training']}, {'name': 'Placebo Mirror Therapy', 'type': 'DEVICE', 'otherNames': ['Mirror Designed by IT Sligo.'], 'description': 'Placebo Mirror Therapy: Participants view the reflective side of a simple mirror which is placed forward/ahead of them in their mid-sagittal plane, and thus cannot see a reflection of either lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.\n\nTreadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.', 'armGroupLabels': ['Placebo Mirror & Treadmill Training']}, {'name': 'Treadmill', 'type': 'DEVICE', 'otherNames': ['Variable speed Treadmill.'], 'description': 'Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.', 'armGroupLabels': ['Mirror Therapy & Treadmill Training', 'Placebo Mirror & Treadmill Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'F91YW50', 'city': 'Sligo', 'state': 'Co Sligo', 'country': 'Ireland', 'facility': 'Institute of Technology, Sligo', 'geoPoint': {'lat': 54.26969, 'lon': -8.46943}}], 'overallOfficials': [{'name': 'Patrick Broderick, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD is shared with any other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Technology, Sligo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research', 'investigatorFullName': 'Dr. John Bartlett', 'investigatorAffiliation': 'Institute of Technology, Sligo'}}}}