Cerebral Palsy
Conditions
Brief summary
Cerebral palsy (CP) in children and adolescents is frequently accompanied by gait abnormalities. Ankle-foot orthoses (AFO) have been suggested to improve the gait pattern. Compared to conventional AFO, modular AFO offer the opportunity to tune its response to the patient's gait characteristics and/or functional maturity. However, the evidence level is still small and AFO tuning is not yet established in clinical routine. The study will investigate individual tuning of custom-built ankle-foot-orthoses (AFO) using gait analyses
Interventions
OTHERbarefoot
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
OTHERshoes only
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
OTHERuntuned AFO with shoes
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order. AFO are walking aids to improve gait pathologies. They are custom-built using plaster casts. AFO for equinus and/or drop foot pathologies are specifically indicated to control excessive ankle plantar flexion. Push-up elements that return the energy from the stance-phase to support lifting the foot during the swing-phase (similar to a spring) are used.
OTHERtuned AFO with shoes
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order. Modular AFO tuning means that patients try different pushup elements with varying stiffness and design before the final design is determined.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order: To determine the order, the 4 conditions will be noted on a piece of paper and randomly picked from an envelope.
Intervention model description
Prospective, cross-sectional within-subjects comparison
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients in outpatient treatment from the University Children's Hospital Basel (UKBB) * Informed Consent provided as documented by signature * Confirmed diagnosis of cerebral palsy * Confirmed diagnosis of spastic equinus and/ or drop foot, * Gait pathologies treated with conventional AFO * Gross Motor Function Classification System (GMFCS) level I or II
Exclusion criteria
* Other neuromuscular diseases * Previous surgical treatment to improve gait pathologies * Injections of Botulinum toxin 6 month prior to study inclusion * Inability or unwillingness to follow the procedures of the gait analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gait profile score (GPS) | at end of study, an average of 1 month | overall score calculated from all kinematic parameters (joint rotation angles) of the affected leg and expressed as the deviation from the normal gait cycle in degrees. The mean GPS was anticipated to be 9° with standard deviation of 1.4° \[2\]. A good (r = 0.5) correlation of GPS for the within-subjects comparison was assumed. The non-inferiority margin was set at the minimally clinically important difference of 1.6°. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement analysis profile (MAP) | at end of study, an average of 1 month | calculated from kinematic parameters and expressed as the deviation from the normal gait cycle in degrees. The MAP consists of individual scores for each joint rotation angle (pelvic tilt, pelvic obliquity, pelvic rotation, hip flexion/extension, hip abduction/adduction, hip rotation, knee flexion/extension, ankle dorsiflexion/extension and foot progression) of the affected leg |
| spatio-temporal parameter | at end of study, an average of 1 month | calculated from kinematic parameters and expressed as the deviation from the normal gait cycle in degrees,Spatio-temporal parameters are walking speed (m/s), cadence (steps/min x 100) and stride length (m) of the affected leg |
Countries
Switzerland
Outcome results
None listed