Traumatic Brain InjuryNCT02839369
Walking Dynamic Among Children With Brain Damge
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 goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Palsy
- What is being tested?
- walking under varies conditions
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Dec 2016
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children post Traumatic Brain Injury with Cerebral palsy Typically Developed
Who may be able to join
- Post Traumatic Brain Injury
- 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 13 years
- Independent ambulation (foot orthoses permitted)
- Children with Cerebral palsy
Show all 11Show fewer
- GMFCS 1 or 2
- Ages 7 to 13 years
- Able to stand up from a chair independently and maintain standing for more than 5 seconds without falling, without obvious limitation in the passive range of motion of lower extremities.
- Typically Developed age and sex controls exclusion criteria:
- Children who could not fulfill simple instructions
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Changing Walking Conditions on Walking Dynamic Characteristics Among Children Post a Severe Traumatic Brain Injury, Cerebral Palsy and Typically Developed (TD) Control.
The goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.
Read the detailed description
leisure time physical activity by the Godin and Shephard (G\&S) questionnaire. Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT). Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.
- Conditions
- Traumatic Brain Injury, Cerebral Palsy
- Being tested
- walking under varies conditions
- Keywords
- walking performance, Cerebral Palsy, Typically Developed
- 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 under varies conditionsOther
The children were asked to walk an electronic mat, three cycles for each one of the different trials as comfortable regular speed, walking as fast and as slow as possible, walking on straight line etc
walking under varies conditionsOther
walking on electronic walkway under different conditions
| Study group | Role | What they receive |
|---|---|---|
| children | post Traumatic Brain Injury With Cerebral Palsy Typically developed Receives: Other: walking under varies conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
step characteristics
The Gaitrite system - step length and time variability (%).
Measured: 30 minutes
Secondary outcomes (3)
step time
step time in sec
Measured: part of the first assessment
step length
step length in cm
Measured: part of the first assessment
gait velocity
walking velocity (cm/sec),
Measured: part of the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startApr 2009
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839369
- Sponsor's protocol ID
- 158-08
- Status last verified
- Jul 2016
- First submitted
- 28 Feb 2010
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changing Walking Conditions on Walking Dynamic Characteristics Among Children Post a Severe Traumatic Brain Injury, Cerebral Palsy and Typically Developed (TD) Control.
- ClinicalTrials.gov ID
- NCT02839369
- Acronym / sponsor ID
- 158-08
- Conditions
- Traumatic Brain Injury, Cerebral Palsy
- Keywords
- walking performance, Cerebral Palsy, Typically Developed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Jul 2016 (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 goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.
Detailed description
leisure time physical activity by the Godin and Shephard (G\&S) questionnaire. Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT). Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | – | Other: walking under varies conditionspost Traumatic Brain Injury With Cerebral Palsy Typically developed |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children post Traumatic Brain Injury with Cerebral palsy Typically Developed
Key inclusion criteria (11 listed)
- Post Traumatic Brain Injury
- 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 13 years
- Independent ambulation (foot orthoses permitted)
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 |
|---|---|---|
| walking under varies conditionsThe children were asked to walk an electronic mat, three cycles for each one of the different trials as comfortable regular speed, walking as fast and as slow as possible, walking on straight line etc | Other | children |
| walking under varies conditionswalking on electronic walkway under different conditions | Other | children |
Primary outcome
step characteristics
Time frame: 30 minutes
The Gaitrite system - step length and time variability (%).
3 secondary outcomes
step time
Time frame: part of the first assessment
step length
Time frame: part of the first assessment
gait velocity
Time frame: part of the first assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 11 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: status not confirmed, as of the sponsor's last update on 21 Jul 2016. 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?
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?
step characteristics (time frame: 30 minutes). 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 21 Jul 2016.