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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05719532
Other study ID # PMR_Core_Balance_001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2023
Est. completion date August 31, 2023

Study information

Verified date March 2023
Source Johannes Kepler University of Linz
Contact Christian Mittermaier, M.D.
Phone +43 5 7680 83
Email christian.mittermaier@kepleruniklinikum.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of healthy young adults regarding balance, core strength/core stability and physical fitness. Correlation of primary outcome parameters and selected secondary parameters.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 31, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Adequat cognitive and lingual competence - Written informed consent Exclusion Criteria: - low back pain or other painful disorders regarding the spine during the last 6 weeks - Previous spine surgery - Neurologic disease or disease of the vestibular organ - Previous arthroplasty of joints

Study Design


Locations

Country Name City State
Austria Department of Physical Medicine & Rehabilitation, Kepler University Hospital Linz

Sponsors (2)

Lead Sponsor Collaborator
Johannes Kepler University of Linz Kepler University Hospital

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of pressure track (COPT) Posturographic parameter; lower values indicate better postural stability Baseline
Primary Area of sway (AOS) Posturographic parameter; lower values indicate better postural stability Baseline
Primary Core stability test of the Swiss Olympic Medical Center Measurement of Core strength/Core stability in sec; higher values indicate better core strength Baseline
Secondary Baecke Questionnaire of Habitual Physical Activity (BQHPA) Questionnaire of physical fitness; higher values indicate higher physical fitness Baseline
Secondary Stability energy Posturographic parameter, measures economy of movement; higher values mean lower stabilty Baseline
Secondary Harmony index Posturographic parameter Baseline
Secondary Frequency of sway Posturographic parameter Baseline
Secondary Feedback Posturographic parameter; quantitative data; a score is calculated by the posturographic system to determine the influence of visual, vestibular and somatosensory feedback on postural control Baseline
Secondary Movement control Posturographic parameter; the frequencies of the movement amplitude during the posturographic measurement are calculated and a score for the low and high frequencies is presented. For the lower frequencies (F1, F2) higher values are positive. For the higher frequencies (F3 - F8) lower values are positive. Baseline
Secondary Weight distribution index Posturographic parameter; Center of pressure at beginning of measurement Baseline
Secondary Body mass index (BMI) Relation weight to height Baseline
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