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Completed

NCT Number: NCT03547674

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Basel Children's Hospital (UKBB)

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. gait profile score (GPS)

    Time frame: at end of study, an average of 1 month

    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°.

Secondary outcomes

  1. Movement analysis profile (MAP)

    Time frame: at end of study, an average of 1 month

    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

  2. spatio-temporal parameter

    Time frame: at end of study, an average of 1 month

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: AFO

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2018
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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