Cerebral PalsyNCT04273204
Relationships Between OLST, GMFM and Pedobarographic Values in CP
A study testing one leg standing test, gross motor function measurement, pedobarographic measurement in people with Cerebral Palsy, run by Istanbul Kültür University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- one leg standing test, gross motor function measurement, pedobarographic measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 30 Sep 2018
- 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 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosed unilateral cerebral palsy
- be able to stand on the affected leg for 0 to 30 seconds
Who cannot join
- Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
- Lower limb surgeries
- Mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does One-Leg-Standing Duration Have a Relationship With Gross Motor Function Measurement Scores and Stance Phase for Unilateral Spastic Children
The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait.
The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with UCP; (2) OLST has relationship between GMFM D and E.
Eighteen children with UCP and ten typically developing children (TDC) participated in the study. All participants and their legal guardians signed an informed consent form before participating. Firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated with the GMFM. The TDC group was used for comparison of pedobarographic stance phase stability (T2-T1) and OLST values.
- Conditions
- Cerebral Palsy
- Being tested
- one leg standing test, gross motor function measurement, pedobarographic measurement
- Keywords
- cerebral palsy,, gait,, Gross Motor Function Measurement,, stability,, foot pressure
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one leg standing test, gross motor function measurement, pedobarographic measurementDiagnostic test
OLST:During the OLST,the participants were asked to shoes off,place both hands on their hips and look at a point on the wall at eye level.A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion.The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion.The OLST was repeated three times for each leg.GMFM:To assess standing and walking,running and jumping functions of the UCP group,the D and E dimensions of GMFM were utilized by a certificated physiotherapist.Each item was tested by three trials and the best trial was used.Pedobarography:The participants' plantar pressure was analyzed using pedobarography.For each participant, the pedobarography was calibrated before the assessment.During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence. Three steps were analyzed for each side.
| Study group | Role | What they receive |
|---|---|---|
| UCP Group | Experimental | Not described Receives: Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement |
| Control Group | Other | Not described Receives: Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
One leg standing test (OLST)
During the OLST, the participants were asked to shoes off, place both hands on their hips and look at a point on the wall at eye level. A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion. The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion. The OLST was repeated three times for each leg and the best score was chosen.
Measured: 1 time, baseline of the study
Gross Motor Function Measurement (GMFM)
The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in five dimensions.
A: Lying and Rolling,
B: Sitting,
C: Crawling and Kneeling,
D: Standing, and
E: Walking, Running and Jumping. In our study, To assess standing and walking, running and jumping functions of the UCP group (GMFCs level I and II), the D and E dimensions of GMFM were utilized by a certificated physiotherapist. Each item was tested by three trials and the best trial was scoring between 0-3 points.
Measured: 1 time, baseline of the study
Pedobarographic Measurement
The participants' plantar pressure was analyzed using pedobarography (Tekscan Inc. Mass. USA) with rectangular shape plates (43.59 x 36.88 x 5.77 cm) and 2288 resistive pressure sensors. For each participant, the pedobarography was calibrated before the assessment. During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence with the aid of a metronome. Before the pedobarographic analysis, each participant walked three minutes to adapt to the metronome.Three steps were analyzed for each side (affected and unaffected sides) to evaluate the following parameters i) time of peak force in early stance phase (T1), ii) time of peak force of late stance phase (T2), iii) stance phase stability (T2-T1), iv) duration of total stance phase (TS) and v) ratio (T2-T1/TS). A mean value of each parameter was used for statistical analysis.
Measured: 1 time, baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start10 Jan 2018
- Primary completion15 Mar 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kültür University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Gamze Ertürk, Istanbul Kültür University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273204
- Sponsor's protocol ID
- 2017/397
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 18 Feb 2020
- 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 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does One-Leg-Standing Duration Have a Relationship With Gross Motor Function Measurement Scores and Stance Phase for Unilateral Spastic Children
- ClinicalTrials.gov ID
- NCT04273204
- Acronym / sponsor ID
- 2017/397
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy,, gait,, Gross Motor Function Measurement,, stability,, foot pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul Kültür UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Feb 2020 (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.
The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait.
The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with UCP; (2) OLST has relationship between GMFM D and E.
Eighteen children with UCP and ten typically developing children (TDC) participated in the study. All participants and their legal guardians signed an informed consent form before participating. Firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated with the GMFM. The TDC group was used for comparison of pedobarographic stance phase stability (T2-T1) and OLST values.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCP Group | Experimental | Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement |
| Control Group | Other | Diagnostic Test: one leg standing test, gross motor function measurement, pedobarographic measurement |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosed unilateral cerebral palsy
- be able to stand on the affected leg for 0 to 30 seconds
Key exclusion criteria (3 listed)
- Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
- Lower limb surgeries
- Mental disorders
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 |
|---|---|---|
| one leg standing test, gross motor function measurement, pedobarographic measurementOLST:During the OLST,the participants were asked to shoes off,place both hands on their hips and look at a point on the wall at eye level.A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion.The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion.The OLST was repeated three times for each leg.GMFM:To assess standing and walking,running and jumping functions of the UCP group,the D and E dimensions of GMFM were utilized by a certificated physiotherapist.Each item was tested by three trials and the best trial was used.Pedobarography:The participants' plantar pressure was analyzed using pedobarography.For each participant, the pedobarography was calibrated before the assessment.During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence. Three steps were analyzed for each side. | Diagnostic test | Control Group, UCP Group |
Primary outcome
One leg standing test (OLST)
Time frame: 1 time, baseline of the study
During the OLST, the participants were asked to shoes off, place both hands on their hips and look at a point on the wall at eye level. A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion. The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion. The OLST was repeated three times for each leg and the best score was chosen.
Gross Motor Function Measurement (GMFM)
Time frame: 1 time, baseline of the study
The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in five dimensions. A: Lying and Rolling, B: Sitting, C: Crawling and Kneeling, D: Standing, and E: Walking, Running and Jumping. In our study, To assess standing and walking, running and jumping functions of the UCP group (GMFCs level I and II), the D and E dimensions of GMFM were utilized by a certificated physiotherapist. Each item was tested by three trials and the best trial was scoring between 0-3 points.
Pedobarographic Measurement
Time frame: 1 time, baseline of the study
The participants' plantar pressure was analyzed using pedobarography (Tekscan Inc. Mass. USA) with rectangular shape plates (43.59 x 36.88 x 5.77 cm) and 2288 resistive pressure sensors. For each participant, the pedobarography was calibrated before the assessment. During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence with the aid of a metronome. Before the pedobarographic analysis, each participant walked three minutes to adapt to the metronome.Three steps were analyzed for each side (affected and unaffected sides) to evaluate the following parameters i) time of peak force in early stance phase (T1), ii) time of peak force of late stance phase (T2), iii) stance phase stability (T2-T1), iv) duration of total stance phase (TS) and v) ratio (T2-T1/TS). A mean value of each parameter was used for statistical analysis.
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 18 Feb 2020.
- 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?
A study testing one leg standing test, gross motor function measurement, pedobarographic measurement in people with Cerebral Palsy, run by Istanbul Kültür 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 2 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 18 Feb 2020. 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?
One leg standing test (OLST) (time frame: 1 time, baseline of the study). The study lists 3 primary outcomes in all. 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 18 Feb 2020.