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

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ClinicalTrials.gov Identifier: NCT03547674
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: barefoot Other: shoes only Other: untuned AFO with shoes Other: tuned AFO with shoes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Prospective, cross-sectional within-subjects comparison
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral palsy_AFO-Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547674


Contacts
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Contact: Kathrin Bieri, MD PhD ++41 61 704 12 ext 12 kathrin.bieri@ispm.unibe.ch

Locations
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Switzerland
University of Basel Children's Hospital (UKBB) Recruiting
Basel, Switzerland, 4031
Contact: Ercih Rutz, PD MD    +41 61 704 ext 1212    erich.rutz@ukbb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Erich Rutz, PD MD Universitäts-Kinderspital beider Basel (UKBB)

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03547674     History of Changes
Other Study ID Numbers: 2018-00541
ks17Rutz3 ( Other Identifier: CTU Basel )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases