Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT01000168
Status:
COMPLETED
Last Update Posted:
2009-10-23
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treadmill Therapy and Brain Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D001930', 'term': 'Brain Injuries'}], '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': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-22', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs).', 'timeFrame': '0, 5 weeks and 10 weeks.'}], 'secondaryOutcomes': [{'measure': 'EU-Walking Index. Time of "Shorter transfer". Time of "Climbing stairs". Performance of climbing stairs. Heart rate registration. * Temporospatial 3D gait data (a sub group analysis). ** Semistructured interview.', 'timeFrame': '0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brain Injury', 'Rehabilitation', 'Treadmill therapy'], 'conditions': ['Cerebral Stroke', 'Hemiplegia', 'Moderate to Severe Functional Impairments']}, 'referencesModule': {'references': [{'pmid': '16235304', 'type': 'BACKGROUND', 'citation': 'Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002840. doi: 10.1002/14651858.CD002840.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Introduction.\n\n* There is a demand for evidence whether treadmill therapy is more efficient than traditional walking training as an intervention for patients with hemiplegia after cerebral stroke.\n\nDesign.\n\n* A randomized controlled trial.\n\nMaterial.\n\n* Stroke patients with moderate to severe functional deficits referred to inpatient medical rehabilitation.\n\nMethod.\n\n* Comparing a treatment group receiving treadmill training with body weight support with a treatment group receiving conventional walking training.\n\nStudy aim:\n\n* Investigate whether treadmill therapy is more effective than traditional functional training in restoring walking and transfer in patients with moderate to severe ambulatory deficits after stroke.', 'detailedDescription': 'See "Brief Summary".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cerebral stoke\n* Hemiplegia\n* Primary rehabilitation\n* Medical stable\n* Wheelchair user\n* Dependent of assistance for walking\n* Dependent of maximum one person for transfer\n* No physical impairments that could prevent walking ability from being restored\n* Able to participate in the training modalities\n\nExclusion Criteria:\n\n* Medical unstable\n* Orthopaedic or other impairments preventing relearning walking\n* Cognitive impairments that prevents understanding the study information\n* Cognitive or psychological impairments that prevents study collaboration'}, 'identificationModule': {'nctId': 'NCT01000168', 'briefTitle': 'Treadmill Therapy and Brain Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Sunnaas Rehabilitation Hospital'}, 'officialTitle': 'The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke', 'orgStudyIdInfo': {'id': '20624506 (SunHF)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill therapy', 'description': 'Patients assigned to the "Treadmill therapy group" received daily 30 minutes specific walking training on "treadmill with body weight support" alternatively overground, and 30 minutes functional training, treated by a physiotherapist.', 'interventionNames': ['Other: Treadmill therapy and conventional walking therapy.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional walking therapy', 'description': 'Patients assigned to the comparative conventional walking therapy group received daily 30 minutes specific traditional walking training overground and 30 minutes functional training, treated by a physiotherapist.', 'interventionNames': ['Other: Treadmill therapy and conventional walking therapy.']}], 'interventions': [{'name': 'Treadmill therapy and conventional walking therapy.', 'type': 'OTHER', 'otherNames': ['Treadmill training with body weight support (TTBWS).', 'Laufband Therapy', 'Traditional walking therapy'], 'description': 'The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks.\n\nThe conventional group received traditional walking therapy for the same time period.', 'armGroupLabels': ['Conventional walking therapy', 'Treadmill therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1450', 'city': 'Nesoddtangen', 'state': 'Bjørnemyrveien 11', 'country': 'Norway', 'facility': 'Department of Brain Injury, Sunnaas Rehabilitation Hospital', 'geoPoint': {'lat': 59.86244, 'lon': 10.66308}}], 'overallOfficials': [{'name': 'Liv Inger Strand, Dr. philos', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnaas Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bergen', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Johan K Stanghelle, Professor MD', 'oldOrganization': 'Sunnaas Rehabilitation Hospital, 1450 Nesoddtangen, Norway'}}}}