Comparison of Dual Task Gait Characteristics in Individua... | NCT04392466

Studies
Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals

NCT04392466

Sponsor

Hacettepe University

Status

Unknown status

Last Update Posted

May 21, 2020Actual

Enrollment

57Estimated

Phase

Not provided

Conditions

Dual Task
Amputation
Gait

Interventions

walking on the treadmill

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2020Actual

Primary Completion Date

Jun 12, 2021Estimated

Completion Date

Jun 15, 2022Estimated

First Submitted Date

May 13, 2020

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2020

Last Update Posted Date

May 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Senem Demirdel, PhD, Pricipal Investigator, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Transtibial amputees	People who use transtibial prosthesis.	Other: walking on the treadmill
Transfemoral amputees	People who use transfemoral prosthesis.	Other: walking on the treadmill
Healty individuals	Healty individuals	Other: walking on the treadmill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
walking on the treadmill	Other	Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.	Healty individuals Transfemoral amputees

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Walking speed	Distance per second	Two minutes
Coefficient of variation	Stride length variability coefficient	Two minutes

Secondary Outcomes

Measure	Description	Time Frame
Step length	Length of right and left steps in cm	Two minutes
Time on each foot	The period on right foot and left foot	Two minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Transtibial amputees, Transfemoral amputees, Healty individuals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Senem Demirdel, PhD	Contact	+905432168216		fzt_sb@hotmail.com
Senem Demirdel, PhD	Contact	+903213051576	138	sdemirdel@hacettepe.edu.tr

Overall Officials

Name	Affiliation	Role
Fatih Erbahçeci, Prof	Hacettepe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepeu	Recruiting	Ankara	Altındağ	06100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34741932	Derived	Demirdel S, Erbahceci F, Yazicioglu G. The effects of cognitive versus motor concurrent task on gait in individuals with transtibial amputation, transfemoral amputation and in a healthy control group. Gait Posture. 2022 Jan;91:223-228. doi: 10.1016/j.gaitpost.2021.10.036. Epub 2021 Oct 27.