NCT03791047

Brief Summary

This study evaluates muscle thickness of trunk and lower limb and balance in young and older healthy adults. The participants will be evaluated muscle thickness for 14 different muscle and balance which evaluated by computerized force plate system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable healthy

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

First Submitted

Initial submission to the registry

December 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

January 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 12, 2019

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

December 29, 2018

Last Update Submit

March 10, 2019

Conditions

Keywords

BalancePostural controlMuscleOlder adults

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. 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

Secondary Outcomes (4)

  • Muscle thickness

    30 minutes

  • Postural Sway

    15 minutes

  • Fear of falling

    15 minutes

  • Joint position sense

    15 minutes

Study Arms (2)

Experimental Group: Balance analysis

EXPERIMENTAL

Sixty older subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.

Other: Balance Analysis

Control Group:Balance Analysis

ACTIVE COMPARATOR

Sixty young subjects will be evaluated in this study. Muscle thickness and balance will be assessed by ultrasonography and Computerized Balance system respectively.

Other: Balance Analysis

Interventions

Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.

Control Group:Balance AnalysisExperimental Group: Balance analysis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be a volunteer to participate
  • to be an aged 18-40 years old.
  • To be a volunteer to participate
  • to be an aged 65-90 years old.

You may not qualify if:

  • Walking with assist device
  • Having a visual deficits
  • Having an orthopedic problems that affect balance
  • Having a neurological disorders
  • Having a musculoskeletal disorders that affect balance
  • Having an undergone orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozkal O, Kara M, Topuz S, Kaymak B, Baki A, Ozcakar L. Assessment of core and lower limb muscles for static/dynamic balance in the older people: An ultrasonographic study. Age Ageing. 2019 Nov 1;48(6):881-887. doi: 10.1093/ageing/afz079.

Study Officials

  • Ozden Ozkal

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 2, 2019

Study Start

January 5, 2019

Primary Completion

February 15, 2019

Study Completion

March 1, 2019

Last Updated

March 12, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations