Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral palsy_AFO-Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- gait profile score (GPS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
gait profile score (GPS)
Time Frame: 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 Outcomes
- spatio-temporal parameter(at end of study, an average of 1 month)
- Movement analysis profile (MAP)(at end of study, an average of 1 month)