Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: barefoot; Other: shoes only; Other: untuned AFO with shoes; Other: tuned AFO with shoes

• Registration Number: NCT03547674
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-06
• Study Start: 2019-01-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
barefoot	barefoot	Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
shoes only	shoes only	Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
untuned AFO with shoes	untuned 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.
tuned AFO with shoes	tuned 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Basel Children's Hospital (UKBB); 🇨🇭 Basel, Switzerland