- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03333434
Effectiveness Ankle-7 Orthosis VS HAFO Orthosis on Gait in Diplegic CPChildren
Effectiveness of Ankle-7 Orthosis vs HAFO Orthosis on Gait Performance in Diplegic Cerebral Palsied Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The project is divided into the following phases:
T0 - at the beginning of the study children included will be subject to the following procedures and assessments:
- demographic and anthropometric data collection;
randomization by concealed allocation to one of the following two groups:
- AFO - Ankle_7 group
- Ankle-7 - AFO group Both, AFO and ankle-7, will be tailored to the patient
The two groups are distinguished by the order of the assignment of the two orthoses, respectively defined as the first assignment orthosis (O_1) and second assignment orthosis (O_2). The first group will use the orthoses AFO as a first assignment and then the orthoses Ankle_7, while the second group will use the two orthoses according to the reverse order. The two will be used with the same orthotic footwear, with the exception of the cases where it will be necessary to change it due to accretion.
- collection of the measures necessary for making the two orthotic devices at OttoBock of Reggio Emilia
- training in the use of the orthoses according to a standardized protocol;
- try on the patient's in-process first assignment orthoses (O_1) and subsequent delivery of them (see Annex A);
Subsequently, the patient will use O_1 for a period of 4-6 weeks.
T1 - patients will receive the following procedures and assessments:
- try on the patient's in-process second assignment orthoses (O_2)
- instrumental gait analysis and video recording of the walking while using O_1 (covered by elastic gaiters);
- withdrawal of O_1
- delivery of O_2 to the patient
Subsequently, the patient will use O_2 for a period of 4-6 weeks.
T2 - patients will undergo the following procedures and evaluations:
- instrumental gait analysis and video recording of the walking while using O_2 (covered by elastic gaiters);
- return of O_1 to the patient;
- Delivery of the diaries and directions for completing and mailing back them at the end of the follow-up period;
T3 - three months follow-up to detect the preference of use of AFO or Ankle-7 (by the child/parent)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - Clinical indication to the use of orthoses to improve the walking function confirmed by instrumental parameters obtained from analysis of the path (dynamic electromyography, optoelectronic stereophotogrammetry analysis);
- Patients who already have AFO orthoses (or ankle-7) that need to be renewed;
- Patients with new clinical indication to the use of orthoses but not yet in possession of the same;
- Informed consent from parents / guardians of the child
Exclusion Criteria:
- Cognitive disabilities that may affect the child's participation in the activities related to this study, in the opinion of the investigators;
- Lower limbs sensory disability that may affect any beneficial effects of the use of the orthoses, in the opinion of the investigators;
- Other diseases associated or not associated with PCI that, according to investigators, could affect the child's participation in the activities related to this study (eg: drug-resistant epilepsy);
- Administration of antispasmodic drugs in the last 6 months;
- Functional surgery of the lower limbs in the last 6 months;
- Indication for surgical treatment to be carried out within 6 months after the date of inclusion in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: AFO - Ankle_7 group
AFO is active comparator, ANKLE7 is the experimental treatment
|
|
Other: Ankle-7 - AFO group
AFO is active comparator, ANKLE7 is the experimental treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from right and left ankle joints power generation in stance phase after the use of first orthosis to right and left ankle joints power generation in stance phase after the use of second orthosis
Time Frame: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
Measured by instrumental gait analysis (ratio of watt to kilogram)
|
After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
knee joint kinematics
Time Frame: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
average extension in degrees of the right and left knees during initial contact, loading response and mid-stance measured by instrumental gait analysis
|
After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
stride length
Time Frame: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
stride length right and left leg, measured by instrumental gait analysis (percentage of height)
|
After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
walking speed
Time Frame: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
walking speed measured by instrumental gait analysis (ratio of percentage of height to seconds)
|
After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
preference of use of AFO or Ankle_7
Time Frame: After a 4-6 week period of use of first orthosis, after a 4-6 week period of use of second orthosis and after 3 months after three months when the child could freely use both orthoses
|
determined from a self- compiled diary
|
After a 4-6 week period of use of first orthosis, after a 4-6 week period of use of second orthosis and after 3 months after three months when the child could freely use both orthoses
|
clinical evaluation of the walking function
Time Frame: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
Using video-recording of children during walking and the Visual Gait Assessment Scale (OGS).
(Boyd R, Graham HK. 1999)
|
After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adriano Ferrari, University of Modena and Reggio Emilia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDGEE_2012_OTTObock
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey