Brain InjuryNCT00338858
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
A study testing walking and balance performance evaluation and muscle strength, walking and balance performance in people with 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 explore the connection between gait variability parameters and balance performance in children with physical disability Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Cerebral Palsy
- What is being tested?
- walking and balance performance evaluation and muscle strength, walking and balance performance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Apr 2008
- 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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3 years of age and older Ambulate, with or without an aid
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Alyn Pediatric and Adolescent Rehabilitation Center
Jerusalem, 91090
About this study
The purpose of this study is to explore the connection between gait variability parameters and balance performance in children with physical disability
Read the detailed description
Step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (EEI) and rating of perceived exertion (OMNI scale).
- Conditions
- Brain Injury, Cerebral Palsy
- Being tested
- walking and balance performance evaluation, muscle strength, walking and balance performance
- Medical subject headings
- Brain Injuries, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking and balance performance evaluationOther
muscle strength, walking and balance performanceProcedure or surgery
HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | TD Receives: Other: walking and balance performance evaluation; Procedure: muscle strength, walking and balance performance |
| 2 | Experimental | TBI Receives: Other: walking and balance performance evaluation; Procedure: muscle strength, walking and balance performance |
| a | Experimental | Cerebral palsy Receives: Other: walking and balance performance evaluation; Procedure: muscle strength, walking and balance performance |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hemda Rotem, PT, Principal investigator, Alyn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338858
- Sponsor's protocol ID
- alyn2CTIL
- Status last verified
- Jun 2006
- First submitted
- 19 Jun 2006
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
- ClinicalTrials.gov ID
- NCT00338858
- Acronym / sponsor ID
- alyn2CTIL
- Conditions
- Brain Injury, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Jun 2006 (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 explore the connection between gait variability parameters and balance performance in children with physical disability
Detailed description
Step length and step time variability will be measured with an electronic walkway, strength of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer, walking performance as will be assessed by the 2 minute walk test, energy expenditure index (EEI) and rating of perceived exertion (OMNI scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: walking and balance performance evaluation, Procedure: muscle strength, walking and balance performanceTD |
| 2 | Experimental | Other: walking and balance performance evaluation, Procedure: muscle strength, walking and balance performanceTBI |
| a | Experimental | Other: walking and balance performance evaluation, Procedure: muscle strength, walking and balance performanceCerebral palsy |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 3 years of age and older Ambulate, with or without an aid
- -
Key exclusion criteria (1 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 and balance performance evaluation | Other | 1, 2, a |
| muscle strength, walking and balance performanceHHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test | Procedure or surgery | 1, 2, a |
Primary outcome
Not reported in the source record.
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 15 Feb 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.
Hemda Rotem, PT principal investigator
Alyn Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking and balance performance evaluation and muscle strength, walking and balance performance in people with 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 2 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 15 Feb 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 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.
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 15 Feb 2011.