Motor Skills in Deaf ChildrenNCT01352364
Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic
A study testing physiotherapy intervention in people with Motor Skills in Deaf Children and Deafness, run by University of the Sinos Valley at 1 site in Brazil.
Trial summary
This study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Motor Skills in Deaf Children, Deafness
- What is being tested?
- physiotherapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Dec 2009
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 7 to 10 years of age.
- hearing disorders proven by presenting specific examination of Auditory Evoked Potential and Examination of the brainstem (Brainstem Evoked Response - Bera).
- consent of parents / guardians of children to participate in the study by signing Term of Informed Consent (IC).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Municipal School For Elementary School Helen Keller
Caxias do Sul, Rio Grande do Sul
About this study
This study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. This study was quasi-experimental before and after, with 10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and post test KTK Coordination Body, and the activities were held once a week for six weeks in sessions of forty minutes. It was used for statistical analysis the Student t test dependent and independent (p ≤ 0.05).
- Conditions
- Motor Skills in Deaf Children, Deafness
- Being tested
- physiotherapy intervention
- Keywords
- Physiotherapy., Deafness., Postural balance., Motor skills.
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapy interventionOther
a program of physical therapy intervention can match or improve motor skills in the deaf children
| Study group | Role | What they receive |
|---|---|---|
| deaf children | Experimental | Not described Receives: Other: physiotherapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Measured: two months
Secondary outcomes (1)
motor coordination
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Skills in Deaf ChildrenStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Sinos Valley
- Sponsor type
- University, hospital or other
- Investigators
- Fernanda Rombaldi Bernardi, Physiotherapist, Principal investigator, University of the Sinos Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352364
- Sponsor's protocol ID
- I01
- Status last verified
- Jul 2009
- First submitted
- 10 May 2011
- Last updated
- 30 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis Of Equilibrium And Motor Coordination Of Deaf Children's Pre And Post Intervention Physiotherapeutic
- ClinicalTrials.gov ID
- NCT01352364
- Acronym / sponsor ID
- I01
- Conditions
- Motor Skills in Deaf Children, Deafness
- Keywords
- Physiotherapy., Deafness., Postural balance., Motor skills.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of the Sinos ValleyUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 May 2011 (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.
This study aimed to assess and reassess the balance and motor skills of deaf children, passed six weeks of intervention and to verify whether a program of physical therapy intervention can match or improve motor skills. This study was quasi-experimental before and after, with 10 children from a school in Caxias do Sul / RS. Motor skills were evaluated using pre and post test KTK Coordination Body, and the activities were held once a week for six weeks in sessions of forty minutes. It was used for statistical analysis the Student t test dependent and independent (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deaf children | Experimental | Other: physiotherapy intervention |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 7 to 10 years of age.
- hearing disorders proven by presenting specific examination of Auditory Evoked Potential and Examination of the brainstem (Brainstem Evoked Response - Bera).
- consent of parents / guardians of children to participate in the study by signing Term of Informed Consent (IC).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| physiotherapy interventiona program of physical therapy intervention can match or improve motor skills in the deaf children | Other | deaf children |
Primary outcome
Balance
Time frame: two months
1 secondary outcome
motor coordination
Time frame: two months
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 30 May 2011.
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.
Fernanda Rombaldi Bernardi, Physiotherapist principal investigator
University of the Sinos Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy intervention in people with Motor Skills in Deaf Children and Deafness, run by University of the Sinos Valley 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 3 inclusion and 0 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 30 May 2011. 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?
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?
Balance (time frame: two months). 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 30 May 2011.