Healthy volunteers
Conditions
Interventions
Group 1: The data collection of the study is divided into three dates per subject. The suitability test for the research project and the data collection are carried out individually with each subject.
Sponsors
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The research project will include subjects who can walk without pain. The gender or ethnicity does not play a role. The age of the participants should be between 18 and 70 years. This restriction is chosen because from the age of 18 years no relevant change in gait pattern due to longitudinal growth is to be expected. From an age of 70 years onward, increasing health problems are to be expected, which could affect the gait pattern or walking safety.
Exclusion criteria
Exclusion criteria: Since this study utilizes a treadmill, persons with unsafe gait patterns will be excluded. To detect possible criteria for exclusion, a personal interview will be held and the "2-minute walk test" will be performed. In the admission interview the following points are asked by the investigator and documented pseudonymously. Each individual item represents an exclusion criterion. Subjects will be excluded who indicate: - NAS > 0 when walking and are therefore currently not pain-free when moving - Using a walking aid - Suffer from an acute illness, such as fever, not yet healed injuries, dizziness, nausea, balance problems - Chronic diseases that influence movement behaviour, gait safety and balance, for example Parkinson's disease, hemiplegia, polyneuropathy - Suffer from fluctuating disease progression, e.g. multiple sclerosis - Medication that affect vigilance, muscle tone, or the central nervous system - Back contour changes due to large scars, a BMI = 30kg/m² or tattoos on the back - Pregnancy - Persons who are not able to give their full consent or insight
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome criterion is to determine the proportion of intra-individual variance between the different measurements. This is to assess the consistency of the individual movement pattern. For this purpose, 25 subjects are examined on 3 different days within one month: The first two appointments are made on consecutive days, the 3rd measurement is made after 30 days. Elegibility and freedom from pain will be queried before data collection and will be determined by means of the standardized 2-minute walking test. This is followed by an acclimatisation to walking on the treadmill at moderate speed. Afterwards, 3 reflective marker points are applied to Acromina and Vertebra prominens. Then the participant is measured at speeds of 2km/h and 4km/h. The consistency of the individual movement patterns can be determined by an Intra Class Correlation Coefficient (ICC). The ICC describes the proportion of variation between the test persons in relation to the variation of all measurements. The ICC takes on values between 0 and 1. With an ICC of 0, the total observed variation is within the subjects, i.e. all test subjects would show the same gait pattern and all differences would be explained by measurement inaccuracy. With an ICC of 1, the total observed variation is between the subjects, i.e. the same value would have been measured for the same subject in every measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome criterion is the effect of a possible influence of the physical activity status of a subject on the individual repeatability of the movement pattern. The secondary questions are considered exploratively without adjustment for multiple testing. Descriptive analyses for binary and categorical data are given with relative and absolute frequencies. For continuous and ordinal variables the mean, standard deviation, median, interquartile range, minimum and maximum are given. | — |
Countries
Germany
Contacts
Public ContactFriederike Werthmann
Doktorandin im Institut für Physikalische Therapie, Prävention und Rehabilitation der Universitätsmedizin Mainz
Outcome results
None listed