NCT04392466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

May 13, 2020

Last Update Submit

May 20, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Walking speed

    Distance per second

    Two minutes

  • Coefficient of variation

    Stride length variability coefficient

    Two minutes

Secondary Outcomes (3)

  • Step length

    Two minutes

  • Time on each foot

    Two minutes

  • Average step cycle

    Two minutes

Study Arms (3)

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

Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.

Healty individualsTransfemoral amputeesTranstibial amputees

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Transtibial amputees, Transfemoral amputees, Healty individuals

You may qualify if:

  • Using a transtibial or transfemoral prosthesis for at least 1 year,
  • Between the ages of 18-65,

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepeu

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Fatih Erbahçeci, Prof

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Senem Demirdel, PhD

CONTACT

Senem Demirdel, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Pricipal Investigator

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 18, 2020

Study Start

February 15, 2020

Primary Completion

June 12, 2021

Study Completion

June 15, 2022

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations