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

University Hospital Basel

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: shoes only; Other: barefoot; Other: untuned AFO with shoes; Other: tuned AFO with shoes

Study type: Interventional

Funder types: Other

Identifiers

NCT03547674

2018-00541

ks17Rutz3 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5 participants in 4 patient groups

barefoot

Active Comparator group

Description:

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

Treatment:

Other: barefoot

shoes only

Active Comparator group

Description:

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

Treatment:

Other: shoes only

untuned AFO with shoes

Active Comparator group

Description:

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

Treatment:

Other: untuned AFO with shoes

tuned AFO with shoes

Experimental group

Description:

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

Treatment:

Other: tuned AFO with shoes