Walking PerformanceNCT01158027
Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS) Damage
An observational study of Walking Performance, run by Sheba Medical Center.
Trial summary
The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Walking Performance
- What is being tested?
- gait evaluation
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to not given
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Fifteen children post-TBI and fifteen typically control.
Who may be able to join
- post-severe closed head injury (Glasgow Coma Scale [GCS] score at admission to emergency room of ≤8) [Kathryn 2008].
- at least one year post trauma.
- ages 7 to 13 years.
- independent ambulation (foot orthoses permitted).
Who cannot join
- had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months.
- unable to follow simple instructions.
About this study
Official title: Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS)
The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls.
- Conditions
- Walking Performance
- Being tested
- gait evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait evaluationOther
The children will asked to walk under different conditions: (1) walking at a self-selected speed faster and slower on the GAITRite® system and on a treadmill and while listening and to a metronomeQuoting.
| Study group | Role | What they receive |
|---|---|---|
| children | Not described Receives: Other: gait evaluation |
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 startOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walking PerformanceStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofer Keren, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158027
- Sponsor's protocol ID
- SHEBA-10-7999-OK-CTIL
- Status last verified
- Oct 2011
- First submitted
- 4 Jul 2010
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS)
- ClinicalTrials.gov ID
- NCT01158027
- Acronym / sponsor ID
- SHEBA-10-7999-OK-CTIL
- Conditions
- Walking Performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2011
- 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.
The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | – | Other: gait evaluation |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fifteen children post-TBI and fifteen typically control.
Key inclusion criteria (4 listed)
- post-severe closed head injury (Glasgow Coma Scale [GCS] score at admission to emergency room of ≤8) [Kathryn 2008].
- at least one year post trauma.
- ages 7 to 13 years.
- independent ambulation (foot orthoses permitted).
Key exclusion criteria (2 listed)
- had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months.
- unable to follow 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 |
|---|---|---|
| gait evaluationThe children will asked to walk under different conditions: (1) walking at a self-selected speed faster and slower on the GAITRite® system and on a treadmill and while listening and to a metronomeQuoting. | Other | children |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2011.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Walking Performance, run by Sheba Medical Center.
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 2 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 18 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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 18 Oct 2011.