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

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: barefoot; Other: shoes only; Other: untuned AFO with shoes; Other: tuned AFO with shoes

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University of Basel Children's Hospital (UKBB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: barefoot; Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.	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.
Active Comparator: 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.	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.
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Erich Rutz, PD MD, Universitäts-Kinderspital beider Basel (UKBB)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2018-00541; ks17Rutz3 (Other Identifier: CTU Basel)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No