Traumatic Brain InjuryNCT01840644
Validity and Reliability of Perceived Exertion Rating Scale in Children With Brain Damage
An observational study of Traumatic Brain Injury and Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial summary
The purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Palsy
- What is being tested?
- Walking on treadmill, different velocities and incline
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Dec 2014
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children post severe TBI Children with CP TD control
Who may be able to join
- Children post severe closed head injury (Glasgow Coma Scale [GCS] score at admission to emergency room of ≤8, at least one year post trauma
- Ages 7 to 12 years
- (3) independent ambulation (foot orthoses permitted).
- Children with Cerebral palsy, GMFCS 1 or 2, ages 7 to 12 years. Typically developed controls.
Who cannot join
- Cannot understand simple instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of Perceived Exertion Rating Scale in Children With Traumatic Brain Injury, Cerebral Palsy and Typically Developed
The purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise.
Read the detailed description
walking on a treadmill twice- one weeks interval five intensity level in each session
- Conditions
- Traumatic Brain Injury, Cerebral Palsy
- Being tested
- Walking on treadmill, different velocities and incline
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking on treadmill, different velocities and inclineOther
Also called RPE
Walking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline
| Study group | Role | What they receive |
|---|---|---|
| all participants | Walking on treadmill, different velocities and incline Receives: Other: Walking on treadmill, different velocities and incline |
What is being measured
The primary outcome is the main question the study is designed to answer.
OMNI scale, a pictorial perceived extortion scale for children
Measured: three meetings once a week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Katz, Phd, Study director, Alyn rehabilitation center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840644
- Sponsor's protocol ID
- 920090351
- Status last verified
- Jun 2015
- First submitted
- 15 Feb 2010
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Perceived Exertion Rating Scale in Children With Traumatic Brain Injury, Cerebral Palsy and Typically Developed
- ClinicalTrials.gov ID
- NCT01840644
- Acronym / sponsor ID
- 920090351
- Conditions
- Traumatic Brain Injury, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Apr 2013 (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.
The purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise.
Detailed description
walking on a treadmill twice- one weeks interval five intensity level in each session
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all participants | – | Other: Walking on treadmill, different velocities and inclineWalking on treadmill, different velocities and incline |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children post severe TBI Children with CP TD control
Key inclusion criteria (4 listed)
- Children post severe closed head injury (Glasgow Coma Scale [GCS] score at admission to emergency room of ≤8, at least one year post trauma
- Ages 7 to 12 years
- (3) independent ambulation (foot orthoses permitted).
- Children with Cerebral palsy, GMFCS 1 or 2, ages 7 to 12 years. Typically developed controls.
Key exclusion criteria (1 listed)
- Cannot understand simple instructions
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 |
|---|---|---|
| Walking on treadmill, different velocities and inclineAlso: RPEWalking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline | Other | all participants |
Primary outcome
OMNI scale, a pictorial perceived extortion scale for children
Time frame: three meetings once a week.
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 23 Jun 2015.
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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.
Michal Katz, Phd study director
Alyn rehabilitation center
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 Traumatic Brain Injury and Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
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 1 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 23 Jun 2015. 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 Israel. 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?
OMNI scale, a pictorial perceived extortion scale for children (time frame: three meetings once a week.). 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 23 Jun 2015.