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

Cerebral Palsy Clinical Trial

— AFO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547674
• Other study ID #: 2018-00541
• Secondary ID: ks17Rutz3
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• 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
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
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.
• 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. Modular AFO tuning means that patients try different pushup elements with varying stiffness and design before the final design is determined.

Locations

Country	Name	City	State
Switzerland	University of Basel Children's Hospital (UKBB)	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Schroder JH, Barandun GA, Leimer P, Morand R, Gopfert B, Rutz E. Novel Modular Walking Orthosis (MOWA) for Powerful Correction of Gait Deviations in Subjects with a Neurological Disease. Children (Basel). 2023 Dec 26;11(1):30. doi: 10.3390/children1101003 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait profile score (GPS)	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°.	at end of study, an average of 1 month
Secondary	Movement analysis profile (MAP)	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	at end of study, an average of 1 month
Secondary	spatio-temporal parameter	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	at end of study, an average of 1 month