Research with human participants

Overview of medical research in the Netherlands

Gait analysis in healthy children to obtain normative data for gaitanalysis in children with clubfeet

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Last updated:

Obtain normative data within similar age-range as our clubfoot patients.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational non invasive

ID

NL-OMON47326

Source

ToetsingOnline

Brief title

Gait analysis in children

Condition

  • Other condition

Synonym

controls, healthy children

Health condition

gezonde kinderen

Research involving

Human

Sponsors and support

Primary sponsor :
Catharina-ziekenhuis
Source(s) of monetary or material Support :
SIA RAAK Publiek,Cooperatie Orthopedie Groot Eindhoven (Catharina ziekenhuis/Maxima Medisch Centrum) / Fontys Paramedische Hogeschool

Intervention

Keyword :
Gait analysis, Normative data

Outcome measures

Primary outcome

Maximum dorsal and plantaiflexion of the ankle during gait-cycle.

Secondary outcome

Addition results gaitanalysis: range of motion knee and hip / ankle power /

foot progression angle - intoeing / footpressure.

Stiffness of the foot / diameter of hamstrigs

Background summary

The treatment of children with clubfeet who visit our outpatient clinic is
prospectively followed. Gait analysis, a measurement of the stiffness of the
feet and ultragraphy of the calf-muscles are part of the cohort. Since the
unaffected side in children with unilateral clubfoot is not comparable with a
healthy normal feet we would like to test healthy children to obtain normative
data.

Study objective

Obtain normative data within similar age-range as our clubfoot patients.

Study design

Observational study, including 1 or 2 measument of approximately 60-75 minutes.
If only the stiffness is measured, the duration is estimated at +-15 minutes

Study burden and risks

Measurements will be performed by skilled researchers. Participants and parents
are asked to come to lab for a measurement of approximately 60-75 minutes. If
only the stiffness measure takes place, measurement could take place at
hospital. Considering to unfamiliar location and the unknown measurements it
might be that participants will be slightly tired after testing. No additional
burder and/or risks are expected.

Public
Catharina-ziekenhuis

Michelangelolaan 2
Eindhoven 5623 EJ
NL
Scientific
Catharina-ziekenhuis

Michelangelolaan 2
Eindhoven 5623 EJ
NL

Listed location countries

Netherlands

Age

Children (2-11 years)

Inclusion criteria

- Healthy children, i.e. no congentical / neurological disorders
- Age-matched with clubfootpatients (3-8 years)

Exclusion criteria

- Children who are not able to understand and follow-up instructions
- Children who are not able to perform tasks (e.g. concentration problems)
- Obese children (BMI > 30)

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
50
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL53229.100.15