Cerebral PalsyNCT01158833
Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy (CP)
An observational study of Cerebral Palsy and Diplegia, Spastic, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Cerebral Palsy, Diplegia, Spastic
- What is being tested?
- classification of gait in diplegic children with CP
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Nov 2010
- Phase
- Observational
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: We retrospectively studied children with diplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy);
Who may be able to join
- diplegia and CP;
Who cannot join
- severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
- pharmaco-resistant epilepsy
- behavioural disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy
In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. The investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk.
The aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the Functional performance measure.
- Conditions
- Cerebral Palsy, Diplegia, Spastic
- Being tested
- classification of gait in diplegic children with CP
- Keywords
- Cerebral palsy, diplegia, gait, classification
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classification of gait in diplegic children with CPOther
To determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS.
| Study group | Role | What they receive |
|---|---|---|
| spastic diplegia due to Cerebral Palsy | Not described Receives: Other: classification of gait in diplegic children with CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Mobility Scale (FMS)
correlation between the new classification of diplegic gait and the FMS which classifies the functional mobility in children
Measured: at the age of 12 to 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Principal investigator, Stefania Costi, University of Modena and Reggio Emilia
- Investigators
- Adriano Ferrari, MD, Study chair, University of Modena and Reggio Emilia and Hospital Santa Maria NuovaStefania Costi, PT, Study director, University of Modena and Reggio EmiliaRita Neviani, PT, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158833
- Sponsor's protocol ID
- UDGEE_2010_classdipl
- Status last verified
- Jun 2014
- First submitted
- 6 Jul 2010
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pascale R, Perazza S, Borelli G, Bianchini E, Alboresi S, Paolicelli PB, Ferrari A, Cioni G. The term diplegia should be enhanced. Part III: inter-observer reliability of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):213-20.
PubMed 18418341Cioni G, Lodesani M, Pascale R, Coluccini M, Sassi S, Paolicelli PB, Perazza S, Ferrari A. The term diplegia should be enhanced. Part II: contribution to validation of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):203-11.
PubMed 18418340Ferrari A, Alboresi S, Muzzini S, Pascale R, Perazza S, Cioni G. The term diplegia should be enhanced. Part I: a new rehabilitation oriented classification of cerebral palsy. Eur J Phys Rehabil Med. 2008 Jun;44(2):195-201.
PubMed 18418339
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01158833
- Acronym / sponsor ID
- UDGEE_2010_classdipl
- Conditions
- Cerebral Palsy, Diplegia, Spastic
- Keywords
- Cerebral palsy, diplegia, gait, classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Jul 2010 (estimated)
- 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.
In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. The investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk.
The aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the Functional performance measure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spastic diplegia due to Cerebral Palsy | – | Other: classification of gait in diplegic children with CP |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We retrospectively studied children with diplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy);
Key inclusion criteria (1 listed)
- diplegia and CP;
Key exclusion criteria (3 listed)
- severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
- pharmaco-resistant epilepsy
- behavioural disorders
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 |
|---|---|---|
| classification of gait in diplegic children with CPTo determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS. | Other | spastic diplegia due to Cerebral Palsy |
Primary outcome
Functional Mobility Scale (FMS)
Time frame: at the age of 12 to 17 years
correlation between the new classification of diplegic gait and the FMS which classifies the functional mobility in children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Background: PubMed 18418341Pascale R, Perazza S, Borelli G, Bianchini E, Alboresi S, Paolicelli PB, Ferrari A, Cioni G. The term diplegia should be enhanced. Part III: inter-observer reliability of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):213-20.
- Background: PubMed 18418340Cioni G, Lodesani M, Pascale R, Coluccini M, Sassi S, Paolicelli PB, Perazza S, Ferrari A. The term diplegia should be enhanced. Part II: contribution to validation of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):203-11.
- Background: PubMed 18418339Ferrari A, Alboresi S, Muzzini S, Pascale R, Perazza S, Cioni G. The term diplegia should be enhanced. Part I: a new rehabilitation oriented classification of cerebral palsy. Eur J Phys Rehabil Med. 2008 Jun;44(2):195-201.
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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, MD study chair
University of Modena and Reggio Emilia and Hospital Santa Maria Nuova
Stefania Costi, PT study director
University of Modena and Reggio Emilia
Rita Neviani, PT principal investigator
Azienda USL Reggio Emilia - IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Diplegia, Spastic, run by University of Modena and Reggio Emilia at 1 site in Italy.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Mobility Scale (FMS) (time frame: at the age of 12 to 17 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158833, which also lists 3 linked publications.
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 27 Jun 2014.