Back to resultsTuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy (AFO)
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
barefoot
shoes only
untuned AFO with shoes
tuned AFO with shoes
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
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
Sites / Locations
- University of Basel Children's Hospital (UKBB)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
barefoot
shoes only
untuned AFO with shoes
tuned AFO with shoes
Arm Description
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Outcomes
Primary Outcome Measures
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°.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03547674
First Posted
May 17, 2018
Last Updated
February 1, 2021
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT03547674
Brief Title
Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy
Acronym
AFO
Official Title
Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral palsy_AFO-Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
barefoot
Arm Type
Active Comparator
Arm Description
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Arm Title
shoes only
Arm Type
Active Comparator
Arm Description
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Arm Title
untuned AFO with shoes
Arm Type
Active Comparator
Arm Description
Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
Arm Title
tuned AFO with shoes
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
barefoot
Intervention Description
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
Intervention Name(s)
shoes only
Intervention Description
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
Intervention Name(s)
untuned AFO with shoes
Intervention Description
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
Intervention Name(s)
tuned AFO with shoes
Intervention Description
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 Measure Information:
Title
gait profile score (GPS)
Description
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°.
Time Frame
at end of study, an average of 1 month
Secondary Outcome Measure Information:
Title
Movement analysis profile (MAP)
Description
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
Time Frame
at end of study, an average of 1 month
Title
spatio-temporal parameter
Description
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
Time Frame
at end of study, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathrin Bieri, MD PhD
Phone
++41 61 704 12
Ext
12
Email
kathrin.bieri@ispm.unibe.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erich Rutz, PD MD
Organizational Affiliation
Universitäts-Kinderspital beider Basel (UKBB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Basel Children's Hospital (UKBB)
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ercih Rutz, PD MD
Phone
+41 61 704
Ext
1212
Email
erich.rutz@ukbb.ch
12. IPD Sharing Statement
Learn more about this trial
Tuned Versus Untuned Ankle-foot Orthoses in Children and Adolescents With Cerebral Palsy
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