Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-29 @ 8:39 AM
Study NCT ID:
NCT03094208
Status:
UNKNOWN
Last Update Posted:
2017-03-29
First Post:
2017-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Dual Task Balance Training In Individuals With Above Knee Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gait speed', 'timeFrame': '1 minute', 'description': '10 meter walk test'}], 'secondaryOutcomes': [{'measure': 'gait analysis', 'timeFrame': '1 minute', 'description': 'gait analysis with footprint method'}, {'measure': 'cognition', 'timeFrame': '5 minutes', 'description': 'Montreal Cognitive Assessment'}, {'measure': 'depression', 'timeFrame': '3 minutes', 'description': 'Beck Depression invertory'}, {'measure': 'balance', 'timeFrame': '2 minutes', 'description': 'one leg stance test'}, {'measure': 'balance', 'timeFrame': '1 minute', 'description': 'four square step test'}, {'measure': 'functional mobility', 'timeFrame': '1 minute', 'description': 'timed up and go test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amputation']}, 'referencesModule': {'references': [{'pmid': '26209423', 'type': 'BACKGROUND', 'citation': 'Morgan SJ, Hafner BJ, Kelly VE. The effects of a concurrent task on walking in persons with transfemoral amputation compared to persons without limb loss. Prosthet Orthot Int. 2016 Aug;40(4):490-6. doi: 10.1177/0309364615596066. Epub 2015 Jul 24.'}, {'pmid': '24567664', 'type': 'BACKGROUND', 'citation': 'Kim GY, Han MR, Lee HG. Effect of Dual-task Rehabilitative Training on Cognitive and Motor Function of Stroke Patients. J Phys Ther Sci. 2014 Jan;26(1):1-6. doi: 10.1589/jpts.26.1. Epub 2014 Feb 6.'}, {'pmid': '27006419', 'type': 'BACKGROUND', 'citation': 'Monjezi S, Negahban H, Tajali S, Yadollahpour N, Majdinasab N. Effects of dual-task balance training on postural performance in patients with Multiple Sclerosis: a double-blind, randomized controlled pilot trial. Clin Rehabil. 2017 Feb;31(2):234-241. doi: 10.1177/0269215516639735. Epub 2016 Jul 10.'}, {'pmid': '32653580', 'type': 'DERIVED', 'citation': 'Demirdel S, Erbahceci F. Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Oct;101(10):1675-1682. doi: 10.1016/j.apmr.2020.06.009. Epub 2020 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The people with transfemoral amputation who use mechanical prosthesis will be include to this study. All participants will be assessed and then they will be randomly assigned to two groups. both groups will receive traditional balance trainnig. Study group will also receive dual task balance training. Training will take 4 weeks, 3 days a week. After the training program, both groups will be assessed again and the results will compare.', 'detailedDescription': 'The people who have transfemoral amputation may have poor balance and gait. Many people with lower limb loss report the need to concentration on gait. People with lower limb loss may need to use cognitive resources to monitor and control movements of the prosthetic limb. The need to concentrate on walking may be greater for those with transfemoral amputation. For examine the use of cognitive resources, dual task paradigm may use. Dual task rehabilitative training used in many patients like stroke, Multipl sclerosis osteoporosis. But there is no study about dual task training on amputation. The purpose of this randomized controlled study is to investigate the effects of dual-task balance training on balance and gait of patients with transfemoral amputation as compared with single-task balance training. We hypothesized that dual-task balance training would improve the balance and gait, it would be more effective than single-task balance training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peoples with transfemoral amputations\n* people who use their mechanical prosthetics at least 1 year\n* People who can walk withoud aids\n\nExclusion Criteria:\n\n* People who have the other health conditions'}, 'identificationModule': {'nctId': 'NCT03094208', 'briefTitle': 'The Effects of Dual Task Balance Training In Individuals With Above Knee Amputation', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Effects of Dual Task Balance Training In Indıvıduals With Above Knee Amputation', 'orgStudyIdInfo': {'id': 'GO16/641-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'muscle strengthening, weight transfer, dual task balance exercises, dual task gait exercises.', 'interventionNames': ['Other: dual task balance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'muscle strengthening, weight transfer, balance exercises, gait exercises.', 'interventionNames': ['Other: traditional balance training']}], 'interventions': [{'name': 'dual task balance training', 'type': 'OTHER', 'otherNames': ['Study group will also receive dual task balance training'], 'description': 'balance exercises with cognitive and motor dual tasks', 'armGroupLabels': ['study group']}, {'name': 'traditional balance training', 'type': 'OTHER', 'description': 'balance exercises', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Senem Demirdel, MSc', 'role': 'CONTACT', 'email': 'sdemirdel@hacettepe.edu.tr', 'phone': '+903123051576', 'phoneExt': '138'}], 'overallOfficials': [{'name': 'Fatih Erbahçeci, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hacettepe University', 'investigatorFullName': 'Senem Demirdel', 'investigatorAffiliation': 'Hacettepe University'}}}}