To investigate the differences in participation, motor abilities and function in more dynamic tasks between clubfoot patients with and without relapse and healthy controls.
ID
Source
Brief title
Condition
- Other condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Health condition
gezonde kinderen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximum plantar flexion at toe-off obtained with 3DGA during walking.
Secondary outcome
Mean PEM-CY, motor competence, M-ABC 2, and CAP scores of the different study
groups. Furthermore, secondary study parameters are: kinematic, and kinetic
parameters from the foot, ankle, knee and hip and muscle activity.
Background summary
Relapse after good initial correction of the clubfoot still occurs in clubfoot
patients treated with the Ponseti method. Relapse of the clubfoot results in
differences in foot function of the patients and could therefore also pose
problems during daily life activities and participation. However, little is
known about the difficulties in activity and participation of clubfoot patients
and whether gait impairments can predict or illustrate those difficulties.
Study objective
To investigate the differences in participation, motor abilities and function
in more dynamic tasks between clubfoot patients with and without relapse and
healthy controls.
Study design
Observational study with two measurement sessions where three-dimensional gait
analysis, questionnaire on perceived motor competence, the movement assessment
battery for children 2 (M-ABC 2) and clubfoot assessment protocol (CAP) are
performed. Furthermore, parents are asked to fill in a digital questionnaire
which consists of the Participation and Environment Measure for Children and
Youth (PEM-CY) and M-ABC 2 checklist. Clubfoot relapse patients are measured
pre- and post-treatment.
Study burden and risks
Children and parents will not undergo any risks or hindrance during the
measurements, as the clinical measurements are like the test performed during
their regular treatments/ consults. However, the participant and parents will
spend three hours, divided over two separate day for the measurements.
Dominee Theodor Fliednerstraat 1
Eindhoven 5631 BM
NL
Dominee Theodor Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
Both controls and (relapse) clubfoot patients who:
- Are 5 - 9 years old
- Have parents with sufficient command of the Dutch language
Clubfoot patients who:
- Have idiopathic clubfoot
- Are uni- or bilaterally affected
- Have been primarily treated with the Ponseti method
Relapse clubfoot patients:
- Reoccurrence of one or more clubfoot aspects that requires additional
treatment as judged by the expert opinion of the treating orthopaedic surgeon.
Additional treatment according to regular care includes:
• Non-invasive treatment with physiotherapy,
• Surgical treatment, consisting of a period of bracing followed by one of the
following surgical procedures: a tibialis anterior tendon transfer (TATT),
anterior distal tibial epiphysiodesis (8-plate), or a combination of both
procedures.
Exclusion criteria
Both controls and (relapse) clubfoot patients who:
- Are unable to follow the instructions
- Have obesity, based on their age-category and gender
- Have an underlying syndrome
- Have a neurological disease
Controls who:
- Have problems of the lower extremity
(e.g., hip dysplasia/ broken leg <1year prior to participation)
All clubfoot patients who:
• Did not have their primary treatment in the Netherlands
• Previously received additional surgical treatment (with exception of
re-Achilles tendon tenotomy) for a relapse of their clubfoot.
Design
Recruitment
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 | NL76757.015.21 |