Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04392466
Other study ID # GO 20/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2020
Est. completion date June 15, 2022

Study information

Verified date May 2020
Source Hacettepe University
Contact Senem Demirdel, PhD
Phone +905432168216
Email fzt_sb@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 57
Est. completion date June 15, 2022
Est. primary completion date June 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Hacettepeu Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Walking speed Distance per second Two minutes
Primary Coefficient of variation Stride length variability coefficient Two minutes
Secondary Step length Length of right and left steps in cm Two minutes
Secondary Time on each foot The period on right foot and left foot Two minutes
Secondary Average step cycle Yhe period of step cycle Two minutes
See also
  Status Clinical Trial Phase
Recruiting NCT03947450 - Autologous Volar Fibroblast Injection Into the Stump Site of Amputees Phase 2
Completed NCT04924036 - Qbrexza Cloths for Hyperhidrosis of Amputation Sites Phase 2
Recruiting NCT04839497 - Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees. Phase 2
Recruiting NCT04212299 - Transfemoral Socket Design and Muscle Function N/A
Completed NCT03733054 - Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
Completed NCT03651830 - A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations N/A
Recruiting NCT04725006 - Sensory Responses to Dorsal Root Stimulation N/A
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT04936789 - Clinical Feasibility of the IMES Transradial Prosthesis N/A
Completed NCT01155024 - Clinical Evaluation of Direct Manufactured Prosthetic Sockets Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Terminated NCT00778856 - Hand Transplantation for the Reconstruction of Below the Elbow Amputations N/A
Recruiting NCT00388752 - Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation Phase 1
Active, not recruiting NCT03374319 - Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations N/A
Completed NCT05542901 - Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees N/A
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Recruiting NCT06194838 - Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees N/A
Completed NCT03570788 - HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
Completed NCT05778799 - Physical Activity and Sports for People With Special Needs
Recruiting NCT04804150 - Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System N/A