NCT05597696

Brief Summary

The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 25, 2022

Last Update Submit

October 11, 2023

Conditions

AmputationTraumatic Amputation of Lower Extremity

Keywords

Limits of stabilitySitting balanceStanding balance

Outcome Measures

Primary Outcomes (1)

  • Limits of stability

    Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements in sitting. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance.

    15 minutes

Study Arms (2)

1) Experimental Group: Transfemoral Amputee

Balance assessment in sitting

2) Control Group: Healthy Subjects

Balance assessment in sitting

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.

You may qualify if:

  • Unilateral transfemoral amputation
  • Using their prosthesis for at least 6 months

You may not qualify if:

  • congenital amputee
  • Bilateral lower extremity amputation
  • Central or peripheral vestibular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation

Ankara, Samanpazarı, 06100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

May 1, 2022

Primary Completion

December 31, 2022

Study Completion

July 1, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

TU(1)