Cerebral PalsyNCT05608954
Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study
An observational study of Cerebral Palsy and Physical Therapy Modalities, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Read more about this study
- Who is it for?
- Ages 0 months to 12 years
- Conditions the study is for
- Cerebral Palsy, Physical Therapy Modalities
- What is being tested?
- Bobath Concept, Pediasuit and Locomotor training
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2022to Mar 2024
- How long will I take part?
- 1 Year
- 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 0 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children from 0 to 12 years old, diagnosed with cerebral palsy
Who may be able to join
- clinical diagnosis of Cerebral Palsy
- aged between 0-12 years
- classified in all the levels of the GMFCS
- those responsible agree to release the minor to participate in the study and sign the Free and Informed Consent Form (FICT)
Who cannot join
- have had botulinum toxin applied 6 months before the intervention
- recent surgery
- other physical abnormalities, genetic or severe syndromes.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Franciele Zardo
Porto Alegre, Rio Grande do Sul
Franciele
About this study
Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Any non-progressive central nervous system (CNS) lesion that occurs in the prenatal, perinatal and postnatal period up to 2 years of life is considered CP. Thus, the present work aims to evaluate, monitor and verify the effects of physical therapy interventions on gross motor function, spasticity, balance, muscle activation, fatigue, respiratory system, functionality and social participation in children with cerebral palsy. This work will use some evaluation scales such as the Gross Motor Function Measure (GMFM-66), the Modified Ashworth Scale (MAS), the Early Clinical Assessment of Balance (ECAB), electromyography, the Fatigue Severity Scale and the Pediatric Functional Status. Scale. In addition to questionnaires, which will be applied directly to parents/caregivers, such as the Young Children's Participation and Environment Measure (YC-PEM), the PEDI (Pediatric Evaluation Disability Inventory) and the Goal Attainment Scaling (GAS).
- Conditions
- Cerebral Palsy, Physical Therapy Modalities
- Being tested
- Bobath Concept, Pediasuit, Locomotor training, Stretching, Psychomotricity
- Keywords
- Cerebral Palsy, Physical Therapy Modalities, Longitudinal Studies, Disabled Children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath ConceptOther
Handling of the Bobath Concept
PediasuitOther
Pediasuit
Locomotor trainingOther
Locomotor training
StretchingOther
Active, passive, active-assisted stretching
PsychomotricityOther
Psychomotor skills
Virtual realityOther
Virtual reality
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Modalities | Children diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment. Receives: Other: Bobath Concept; Other: Pediasuit; Other: Locomotor training; Other: Stretching; Other: Psychomotricity; Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function
Measurement of Gross Motor Function
Measured: 1 year
Gross Motor Function Classification System
Scale Gross Motor Function Classification System
Measured: Levels I - V. Higher scores mean a worse outcome
Secondary outcomes (8)
Electromyography
Muscle activation
Measured: 1 year
Early Clinical Assessment of Balance - ECAB
Postural control and balance
Measured: 1 year
Modified Ashworth Scale (MAS)
Muscle tone
Measured: 1 year
Fatigue Severity Scale
Muscle fatigue
Measured: 1 year
Pediatric Functional Status Scale
Functional status
Measured: 1 year
YC-PEM - Young Children's Participation and Environment Measure
Level of participation and qualities of the environment in which these activities take place.
Measured: 1 year
PEDI (Pediatric Evaluation Disability Inventory)
Detailed description of the child's functional performance, documenting its longitudinal changes in three functional areas: self-care, mobility and social function.
Measured: 1 year
GAS (Goal Attainment Scaling)
Evaluation of results obtained in family therapy, or in an intervention program
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start30 Nov 2022
- Primary completionMay 2023 (estimated)
- Study completionMar 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cechetti, Federal University of Health Science of Porto Alegre
- Investigators
- Franciele Zardo, Msc, Principal investigator, UFCSPA: Universidade Federal de Ciencias da Saude de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608954
- Sponsor's protocol ID
- Cerebral Palsy longitudinal
- Status last verified
- Dec 2022
- First submitted
- 5 Feb 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT05608954
- Acronym / sponsor ID
- Cerebral Palsy longitudinal
- Conditions
- Cerebral Palsy, Physical Therapy Modalities
- Keywords
- Cerebral Palsy, Physical Therapy Modalities, Longitudinal Studies, Disabled Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 Nov 2022 (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.
Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Any non-progressive central nervous system (CNS) lesion that occurs in the prenatal, perinatal and postnatal period up to 2 years of life is considered CP. Thus, the present work aims to evaluate, monitor and verify the effects of physical therapy interventions on gross motor function, spasticity, balance, muscle activation, fatigue, respiratory system, functionality and social participation in children with cerebral palsy. This work will use some evaluation scales such as the Gross Motor Function Measure (GMFM-66), the Modified Ashworth Scale (MAS), the Early Clinical Assessment of Balance (ECAB), electromyography, the Fatigue Severity Scale and the Pediatric Functional Status. Scale. In addition to questionnaires, which will be applied directly to parents/caregivers, such as the Young Children's Participation and Environment Measure (YC-PEM), the PEDI (Pediatric Evaluation Disability Inventory) and the Goal Attainment Scaling (GAS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Modalities | – | Other: Bobath Concept, Other: Pediasuit, Other: Locomotor training, Other: Stretching, Other: Psychomotricity, Other: Virtual realityChildren diagnosed with cerebral palsy will be followed longitudinally in their therapies within the physiotherapeutic treatment. |
Who may qualify
- Ages
- 0 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 0 to 12 years old, diagnosed with cerebral palsy
Key inclusion criteria (4 listed)
- clinical diagnosis of Cerebral Palsy
- aged between 0-12 years
- classified in all the levels of the GMFCS
- those responsible agree to release the minor to participate in the study and sign the Free and Informed Consent Form (FICT)
Key exclusion criteria (3 listed)
- have had botulinum toxin applied 6 months before the intervention
- recent surgery
- other physical abnormalities, genetic or severe syndromes.
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 |
|---|---|---|
| Bobath ConceptHandling of the Bobath Concept | Other | Physical Therapy Modalities |
| PediasuitPediasuit | Other | Physical Therapy Modalities |
| Locomotor trainingLocomotor training | Other | Physical Therapy Modalities |
| StretchingActive, passive, active-assisted stretching | Other | Physical Therapy Modalities |
| PsychomotricityPsychomotor skills | Other | Physical Therapy Modalities |
| Virtual realityVirtual reality | Other | Physical Therapy Modalities |
Primary outcome
Gross Motor Function
Time frame: 1 year
Measurement of Gross Motor Function
Gross Motor Function Classification System
Time frame: Levels I - V. Higher scores mean a worse outcome
Scale Gross Motor Function Classification System
8 secondary outcomes
Electromyography
Time frame: 1 year
Early Clinical Assessment of Balance - ECAB
Time frame: 1 year
Modified Ashworth Scale (MAS)
Time frame: 1 year
Fatigue Severity Scale
Time frame: 1 year
Pediatric Functional Status Scale
Time frame: 1 year
YC-PEM - Young Children's Participation and Environment Measure
Time frame: 1 year
PEDI (Pediatric Evaluation Disability Inventory)
Time frame: 1 year
GAS (Goal Attainment Scaling)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Franciele Zardo, Msc principal investigator
UFCSPA: Universidade Federal de Ciencias da Saude de Porto Alegre
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 Physical Therapy Modalities, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Cechetti, PhD ((51) 3303 8776, fernandacec@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function (time frame: 1 year). The study lists 2 primary outcomes in all. 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 14 Dec 2022.