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

NCT03547674 | Completed

• 2 other identifiers: 2018-00541ks17Rutz3
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Movement analysis profile (MAP)

  at end of study, an average of 1 month

• spatio-temporal parameter

  at end of study, an average of 1 month

Study Arms (4)

barefoot

ACTIVE COMPARATOR

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

shoes only

ACTIVE COMPARATOR

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

untuned AFO with shoes

ACTIVE COMPARATOR

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

tuned AFO with shoes

EXPERIMENTAL

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

Interventions

barefoot OTHER

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

barefoot

shoes only 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

untuned AFO with shoes 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.

untuned AFO with shoes

tuned AFO with shoes 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.

tuned AFO with shoes

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Other neuromuscular diseases
• Previous surgical treatment to improve gait pathologies
• Inability or unwillingness to follow the procedures of the gait analysis

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University of Basel Children's Hospital (UKBB)

Basel, 4031, Switzerland

Location

Related 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/children11010030.

  PMID: 38255343 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Community Health Workers; Shoes

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Erich Rutz, PD MD

  Universitäts-Kinderspital beider Basel (UKBB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order: To determine the order, the 4 conditions will be noted on a piece of paper and randomly picked from an envelope.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, cross-sectional within-subjects comparison

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 6, 2018
• Study Start: January 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CH (1)