ExerciseNCT03596021
The Turkish Validity and Reliability of "Toe Walking Scale" in Children With Idiopathic Toe Walking
An observational study of Exercise and Rehabilitation, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
In clinics, many scales have been developed to examine daily living activities and function in children with idiopatic toe walking. "The Idiopatic Toe Walking (ITW)" was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Rehabilitation, Reliability
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Apr 2018
- How long will I take part?
- 1 Week
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: diagnosed with toe walking by the pediatric neurologist and conducted to us.
Who may be able to join
- older than 3 years
- without neurologic, orthopethic or psychiatric illnesses
- still walking on toe
Who cannot join
- absence of any known medical conditions
- no voluntary to participate
- older than 18 years or younger than 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Version of "Toe Walking Scale"
In clinics, many scales have been developed to examine daily living activities and function in children with idiopatic toe walking. "The Idiopatic Toe Walking (ITW)" was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. The aim of the investigator's study was to investigate translating the ITW scale and using it in clinics reliably and valiably with a Turkish version of ITW in children with idiopatic toe walking.
Read the detailed description
Demographic information was recorded which are included gender, age, using orthosis, botox/surgical history, use and duration of walkers/child-runner (WCR). The scale was translated into Turkish with the following translation steps. Thirty four children with idiopatic toe walking were included in the study. Internal structure consistency and test-retest reliability were measured for reliability analyses. For each item on the scale, Cronbach's alpha coefficient and item-total score correlations were calculated. The scale was administered for test-retest reliability at baseline and one week later by one rater. Test-retest reliability was assessed by Pearson's correlation test with observational gait analysis and 'co-validity' was investigated, statistically.
- Conditions
- Exercise, Rehabilitation, Reliability, Validity
- Keywords
- exercise, toe walking, scale, reliability, validity
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
TOE WALKING SCALE
Toe Walking Scale, was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. The scoring of the scale with Yes/No/Not Applicable. All items themed demographics, neurogenic, neuromuscular, traumatic, and combined them.
Measured: First: May 2018 Last: one weeks later
Secondary outcomes (1)
Observational gait analysis
Observational gait analysis applied by the video recording method. The method have seen after the recording from physiotherapist. The observer will be scored the video records.
Measured: First: May 2018 Last: one weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Jan 2018
- Primary completion1 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akın İşcan, Prof, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596021
- Sponsor's protocol ID
- BezmialemMT
- Status last verified
- Jul 2018
- First submitted
- 1 Jun 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of "Toe Walking Scale"
- ClinicalTrials.gov ID
- NCT03596021
- Acronym / sponsor ID
- BezmialemMT
- Conditions
- Exercise, Rehabilitation, Reliability, Validity
- Keywords
- exercise, toe walking, scale, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
In clinics, many scales have been developed to examine daily living activities and function in children with idiopatic toe walking. "The Idiopatic Toe Walking (ITW)" was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. The aim of the investigator's study was to investigate translating the ITW scale and using it in clinics reliably and valiably with a Turkish version of ITW in children with idiopatic toe walking.
Detailed description
Demographic information was recorded which are included gender, age, using orthosis, botox/surgical history, use and duration of walkers/child-runner (WCR). The scale was translated into Turkish with the following translation steps. Thirty four children with idiopatic toe walking were included in the study. Internal structure consistency and test-retest reliability were measured for reliability analyses. For each item on the scale, Cronbach's alpha coefficient and item-total score correlations were calculated. The scale was administered for test-retest reliability at baseline and one week later by one rater. Test-retest reliability was assessed by Pearson's correlation test with observational gait analysis and 'co-validity' was investigated, statistically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- diagnosed with toe walking by the pediatric neurologist and conducted to us.
Key inclusion criteria (3 listed)
- older than 3 years
- without neurologic, orthopethic or psychiatric illnesses
- still walking on toe
Key exclusion criteria (3 listed)
- absence of any known medical conditions
- no voluntary to participate
- older than 18 years or younger than 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TOE WALKING SCALE
Time frame: First: May 2018 Last: one weeks later
Toe Walking Scale, was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. The scoring of the scale with Yes/No/Not Applicable. All items themed demographics, neurogenic, neuromuscular, traumatic, and combined them.
1 secondary outcome
Observational gait analysis
Time frame: First: May 2018 Last: one weeks later
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 Jul 2018.
- 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.
Akın İşcan, Prof study director
Bezmialem Vakif University
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 Exercise and Rehabilitation, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 3 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 Jul 2018. 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 Turkey (Türkiye). 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?
TOE WALKING SCALE (time frame: First: May 2018 Last: one weeks later). 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 Jul 2018.