Cerebral PalsyNCT03333434
Effectiveness Ankle-7 Orthosis VS HAFO Orthosis on Gait in Diplegic CPChildren
A study testing Carbon Ankle Seven spring (A7 - Otto Bock, Germany) and Hinged AFO in people with Cerebral Palsy, run by Azienda USL Reggio Emilia - IRCCS.
Trial summary
Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied children (CP) although the level of scientific evidence to support their use is still moderate. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Carbon Ankle Seven spring (A7 - Otto Bock, Germany) and Hinged AFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2012to 15 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - 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
Who cannot join
- 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.
About this study
Official title: Effectiveness of Ankle-7 Orthosis vs HAFO Orthosis on Gait Performance in Diplegic Cerebral Palsied Children
Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied children (CP) although the level of scientific evidence to support their use is still moderate. Carbon Ankle Seven spring (A7 - Otto Bock, Germany) is specifically designed to store energy when loaded and release it at toe-off in order to improve gait performance with respect to non-energy-storing AFOs. The aim of this work is to verify the superiority of the ankle-7 orthosis compared to the more widespread AFO, to improve the functionality and walking function of children with spastic diplegia and PCI.
Read the 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)
- Conditions
- Cerebral Palsy
- Being tested
- Carbon Ankle Seven spring (A7 - Otto Bock, Germany), Hinged AFO
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Ankle Seven spring (A7 - Otto Bock, Germany)Device
Hinged AFODevice
| Study group | Role | What they receive |
|---|---|---|
| AFO - Ankle_7 group | Other | AFO is active comparator, ANKLE7 is the experimental treatment Receives: Device: Carbon Ankle Seven spring (A7 - Otto Bock, Germany); Device: Hinged AFO |
| Ankle-7 - AFO group | Other | AFO is active comparator, ANKLE7 is the experimental treatment Receives: Device: Carbon Ankle Seven spring (A7 - Otto Bock, Germany); Device: Hinged AFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured by instrumental gait analysis (ratio of watt to kilogram)
Measured: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
Secondary outcomes (5)
knee joint kinematics
average extension in degrees of the right and left knees during initial contact, loading response and mid-stance measured by instrumental gait analysis
Measured: 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
stride length right and left leg, measured by instrumental gait analysis (percentage of height)
Measured: 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
walking speed measured by instrumental gait analysis (ratio of percentage of height to seconds)
Measured: 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
determined from a self- compiled diary
Measured: 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
Using video-recording of children during walking and the Visual Gait Assessment Scale (OGS). (Boyd R, Graham HK. 1999)
Measured: After a 4-6 week period of use of first orthosis and after a 4-6 week period of use of second orthosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start30 Nov 2012
- Primary completion15 May 2017
- Study completion15 Aug 2017
Why it stopped: Difficulties in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- Otto Bock Healthcare Products GmbH
- Responsible party
- Sponsor
- Investigators
- Adriano Ferrari, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333434
- Sponsor's protocol ID
- UDGEE_2012_OTTObock
- Status last verified
- Nov 2017
- First submitted
- 2 Oct 2017
- Last updated
- 12 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ankle-7 Orthosis vs HAFO Orthosis on Gait Performance in Diplegic Cerebral Palsied Children
- ClinicalTrials.gov ID
- NCT03333434
- Acronym / sponsor ID
- UDGEE_2012_OTTObock
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- Otto Bock Healthcare Products GmbH
- Study start
- 30 Nov 2012 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied children (CP) although the level of scientific evidence to support their use is still moderate. Carbon Ankle Seven spring (A7 - Otto Bock, Germany) is specifically designed to store energy when loaded and release it at toe-off in order to improve gait performance with respect to non-energy-storing AFOs. The aim of this work is to verify the superiority of the ankle-7 orthosis compared to the more widespread AFO, to improve the functionality and walking function of children with spastic diplegia and PCI.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFO - Ankle_7 group | Other | Device: Carbon Ankle Seven spring (A7 - Otto Bock, Germany), Device: Hinged AFOAFO is active comparator, ANKLE7 is the experimental treatment |
| Ankle-7 - AFO group | Other | Device: Carbon Ankle Seven spring (A7 - Otto Bock, Germany), Device: Hinged AFOAFO is active comparator, ANKLE7 is the experimental treatment |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Ankle Seven spring (A7 - Otto Bock, Germany) | Device | AFO - Ankle_7 group, Ankle-7 - AFO group |
| Hinged AFO | Device | AFO - Ankle_7 group, Ankle-7 - AFO group |
Primary outcome
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)
5 secondary outcomes
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
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
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
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
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
Results and safety
The study was stopped early (reason given: Difficulties in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriano Ferrari principal investigator
University of Modena and Reggio Emilia
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Ankle Seven spring (A7 - Otto Bock, Germany) and Hinged AFO in people with Cerebral Palsy, run by Azienda USL Reggio Emilia - IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.