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

NCT ID: NCT03547674

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-08-31

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

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

barefoot

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

Group Type: ACTIVE_COMPARATOR

barefoot

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

shoes only

Intervention Type: OTHER

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.

Group Type: ACTIVE_COMPARATOR

untuned AFO with shoes

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

tuned AFO with shoes

Intervention Type: OTHER

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.

Interventions

barefoot

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erich Rutz, PD MD

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Kinderspital beider Basel (UKBB)

Locations

University of Basel Children's Hospital (UKBB)

Basel, , Switzerland

Countries

Switzerland

References

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/children11010030.

Reference Type: RESULT

PMID: 38255343 (View on PubMed)

Other Identifiers

ks17Rutz3

Identifier Type: OTHER

Identifier Source: secondary_id

2018-00541

Identifier Type: -

Identifier Source: org_study_id