- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392466
Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals
Comparison of Cognitive and Motor Dual Task Gait Characteristics in Individuals With Transtibial, Transfemoral Amputation and Healty Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Walking is a complex task in which sensory and cognitive systems must be involved. The lower extremity amputee may need to use cognitive resources to focus on walking, monitor and control the prosthetic movements. The need to use cognitive resources may be higher in those with more proximal level amputation, such as above-knee level. The role of cognition and concentration is revealed by a cognitive task performed with posture and gait control using the dual task method. The dual task paradigm provides information about the automation of the default processes that underpin good performance disclosure. This approach involves performing two tasks at the same time. Dual task is divided into primary task and secondary task. The performance of the primary task while performing a single task is recorded. If there is a drop in performance when the secondary task is added, this indicates that the primary task needs high attention.
In proximal amputations, with the lost of movement system structures, functional impairment increases. Amputation from the proximal level affects daily life activities and walking ability more. Above-knee amputees reported more functional difficulties in ambulatory ambulation than transtibial amputee.
The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Altındağ
-
Ankara, Altındağ, Turkey, 06100
- Recruiting
- Hacettepeu
-
Contact:
- senem demirdel, PhD
- Email: fzt_sb@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Using a transtibial or transfemoral prosthesis for at least 1 year,
- Between the ages of 18-65,
Exclusion Criteria:
- To be diagnosed as a neurological, orthopedic, cognitive disorder,
- Having a condition other than amputation that may affect gait.
- Having different permanent disabilities other than amputation,
- Using walking aid,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Transtibial amputees
People who use transtibial prosthesis.
|
Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.
|
|
Transfemoral amputees
People who use transfemoral prosthesis.
|
Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.
|
|
Healty individuals
|
Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking speed
Time Frame: Two minutes
|
Distance per second
|
Two minutes
|
|
Coefficient of variation
Time Frame: Two minutes
|
Stride length variability coefficient
|
Two minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Step length
Time Frame: Two minutes
|
Length of right and left steps in cm
|
Two minutes
|
|
Time on each foot
Time Frame: Two minutes
|
The period on right foot and left foot
|
Two minutes
|
|
Average step cycle
Time Frame: Two minutes
|
Yhe period of step cycle
|
Two minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GO 20/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amputation
-
Shirley Ryan AbilityLabUniversity of AlbertaActive, not recruitingAmputation | Amputation; Traumatic, Hand | Amputation, Traumatic | Amputation; Traumatic, LimbUnited States
-
Liberating Technologies, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAmputation | Prosthesis User | Amputation; Traumatic, Hand | Amputation, CongenitalUnited States
-
Boninger, Michael, MDNational Institute of Neurological Disorders and Stroke (NINDS); Ripple Therapeutics...RecruitingAmputation | Amputation; Traumatic, HandUnited States
-
Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedAmputation | Amputation; Traumatic, Limb | Upper Limb Amputation at the Hand | Upper Limb Amputation at the WristUnited States
-
Medipol UniversityRecruitingEvaluation of Functionality of Amputees According to the Medicare Functional K Classification SystemAmputation | Amputation; Traumatic, Leg, LowerTurkey
-
Point DesignsEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingAmputation; Traumatic, Hand | Amputation, CongenitalUnited States
-
Shirley Ryan AbilityLabRecruitingAmputation | Amputation, Traumatic | Amputation; Traumatic, Limb | Amputation of KneeUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Amputation; Traumatic, Leg, LowerItaly
-
Fondazione Don Carlo Gnocchi OnlusCompletedAmputation | Traumatic Amputations | Leg AmputationItaly
Clinical Trials on walking on the treadmill
-
Atlas UniversityCompletedFatigue | Autonomous Nervous SystemTurkey
-
University Hospital, GhentUniversity GhentRecruiting
-
University Hospital, GhentUniversity Ghent; Vrije Universiteit Brussel; VU University of AmsterdamRecruiting
-
Laval UniversityTerminatedParkinson's DiseaseCanada
-
Nantes University HospitalCompleted
-
Hopital FochCompletedWalking, DifficultyFrance
-
Meuhedet. Healthcare OrganizationCompleted
-
Samsung Medical CenterCompletedStroke | Gait Disorders, NeurologicKorea, Republic of
-
University of Arkansas, FayettevilleRecruitingDiabetes Mellitus, Type 2United States
-
Alyn Pediatric & Adolescent Rehabilitation HospitalCompletedCerebral Palsy | Traumatic Brain InjuryIsrael