Cerebral Palsy, SpasticNCT04225546
Sit to Stand Movement in Children With Cerebral Palsy
An observational study of Cerebral Palsy, Spastic and Cerebral Palsy, Spastic, Diplegic, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the relationship between trunk control and lower extremity selective motor control during the movement of sit to stand (STS) in children with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Cerebral Palsy, Spastic, Diplegic
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2020to 15 Mar 2020
- How long will I take part?
- 1 Day
- 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 4 to 10 years
- All sexes
- Child
Study population: 16 spastic hemiplegic cerebral palsy patients, 12 spastic diplegic cerebral palsy patients between 4 - 10 years of age, and 32 healthy volunteer peers
Who may be able to join
- Confirmed diagnosis of spastic hemiplegic or diplegic cerebral palsy
- Age between 4 - 10
- Were having a level of 1 or 2 of GMFCS
- Able to stand without any orthosis or special equipment
- No orthopedic surgery or not having Botulinum Toxin-A injection in the last 6 months
- Volunteer to study
Who cannot join
- Having cognitive disorder
- Uncontrolled epilepsy
- Lower extremity contracture that may affect assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
Official title: Relationship Between Sit to Stand Movement, Trunk Control and Selective Motor Control of Lower Extremity in Children With Hemiplegic and Diplegic Cerebral Palsy
The aim of this study is to examine the relationship between trunk control and lower extremity selective motor control during the movement of sit to stand (STS) in children with cerebral palsy (CP).
Read the detailed description
The aim of this study is to examine the relationship between trunk control and lower extremity selective motor control and balance problems during the movement of sit to stand (STS) frequently encountered in children with cerebral palsy (CP) in daily life and to compare the STS performance of in children with CP and typical developing children. CP patients have difficulty in daily life activities due to muscle weakness, lack of muscle coordination, balance and postural control disorders. STS activity, which is one of the most frequently used activities in daily life, is a biomechanical activity in children with CP, requiring neuromuscular coordination and postural control outside of muscle strength. It is not enough to evaluate the muscle strength to evaluate the STS movement which is very important for these group, it is necessary to evaluate the balance of this movement of children with CP and the isolated muscle strengths (selective motor controls) of the lower extremity that we believe may affect this movement. There is not enough information about whether there is a relationship between the trunk controls and the selective motor controls of the lower extremities during the STS movement in children with CP. The information in the literature is limited to the fact that trunk control and muscle strength affect the balance during the STS movement. However, there is no study examining the relationship between selective motor control and trunk control during STS movement in children with CP.
This study, which includes selective motor control and trunk control, aims to eliminate this deficiency in the literature. In addition, the performance of the participants STS movement will be evaluated objectively with the test of the computerized balance device planned to be applied. In this study, to in children with CP; "Modified Ashworth Scale" to evaluate spasticity in the hip, knee and ankle, "Gross Motor Function Classification System" to determine gross motor levels, "Trunk Control Measurement Scale" to measure dynamic and static balance, "Gross Motor Function Measure-88's sitting sub-test" to assess seating function", "Selective Control Assesment of Lower Extremity" to assess the selective motor control of the knee and ankle muscles, the sit to stand test of the computerized postural analysis device will be applied to assess the duration of the STS movement and the deviations during the movement. The application time of the tests varies between 5-30 minutes.
For typical developing children, all tests except the Modified Ashworth Scale and the Gross Motor Function Classification System will be applied from tests applied to children with CP.
This study will evaluate the independence of children with CP in daily life activities and contribute to the correct planning of rehabilitation goals.
- Keywords
- cerebral palsy, selective control, trunk, sit to stand
- Medical subject headings
- Cerebral Palsy, Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients with hemiplegic and diplegic cerebral palsy between 4 - 10 years of age | |
| Control group | Healthy volunteer typically developing peers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale (TCMS)
TCMS measures the state of balance on the support surface and the ability to actively move body parts during functional activities, which are the two components of trunk control. TCMS consists of 15 items in total that are scored on 2, 3 or 4 point ordinal scale and administered bilaterally in case of clinical relevance. The total TCMS score ranges from 0 to 58. A high score on this scale represents a better performance.
Measured: Baseline
Secondary outcomes (5)
Selective Control Assessment of the Lower Extremity
SCALE examines selective voluntary motor control in children with spastic CP. The SCALE tool assesses hip, knee, ankle, subtalar, and toe joints bilaterally.The SCALE tool assigns each joint a score from 0 to 2 points: 2 points, normal; 1 point, impaired; and 0 points, unable. The SCALE score is the sum of scoresfor each joint and assumes a 10 point maximum per limb.
Measured: Baseline
Weight Transfer Time (sec) parameter of sit to stand test of Neurocome Balance Master
Evaluations will be done by Balance Master® device. The weight transfer time was defined as the length of time between the prompt to move and the moment when the COG shifted to over the feet.
Measured: Baseline
Rising Index (%) parameter of sit to stand test of Neurocome Balance Master
The rising index, or the amount of force exerted by the legs to decelerate forward motion of the upper body during the rising phase, expressed as a percent of body weight.
Measured: Baseline
Sway Velocity (deg/sec)
Center of gravity (COG) sway velocity, or the mean velocity of COG sway during the rise to stand and the first five seconds during standing, expressed in degree per second.
Measured: Baseline
Sitting domain of Gross Motor Function Measurement-88 (GMFM-88)
Gross Motor Function Measurement evaluates motor functions in children with Cerebral Palsy. There is 88 items under 5 subdimensions (lying and rolling, sitting, crawling and kneeling, standing, walking-running-jumping. GMFM has a 4-point scoring system for each item. The higher the child gets, the more successful the child is in gross motor function
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start4 Jan 2020 (estimated)
- Primary completion4 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag Saygi, Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225546
- Sponsor's protocol ID
- 09.2019.261
- Status last verified
- Jan 2020
- First submitted
- 4 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the principal investigator (DG). The data are not publicly available due to their containing information that could compromise the privacy of research participants.
Publications
Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.
PubMed 19220390Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.
PubMed 21757321
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sit to Stand Movement, Trunk Control and Selective Motor Control of Lower Extremity in Children With Hemiplegic and Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04225546
- Acronym / sponsor ID
- 09.2019.261
- Keywords
- cerebral palsy, selective control, trunk, sit to stand
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Jan 2020 (estimated)
- Primary completion
- 4 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 13 Jan 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 aim of this study is to examine the relationship between trunk control and lower extremity selective motor control during the movement of sit to stand (STS) in children with cerebral palsy (CP).
Detailed description
The aim of this study is to examine the relationship between trunk control and lower extremity selective motor control and balance problems during the movement of sit to stand (STS) frequently encountered in children with cerebral palsy (CP) in daily life and to compare the STS performance of in children with CP and typical developing children. CP patients have difficulty in daily life activities due to muscle weakness, lack of muscle coordination, balance and postural control disorders. STS activity, which is one of the most frequently used activities in daily life, is a biomechanical activity in children with CP, requiring neuromuscular coordination and postural control outside of muscle strength. It is not enough to evaluate the muscle strength to evaluate the STS movement which is very important for these group, it is necessary to evaluate the balance of this movement of children with CP and the isolated muscle strengths (selective motor controls) of the lower extremity that we believe may affect this movement. There is not enough information about whether there is a relationship between the trunk controls and the selective motor controls of the lower extremities during the STS movement in children with CP. The information in the literature is limited to the fact that trunk control and muscle strength affect the balance during the STS movement. However, there is no study examining the relationship between selective motor control and trunk control during STS movement in children with CP.
This study, which includes selective motor control and trunk control, aims to eliminate this deficiency in the literature. In addition, the performance of the participants STS movement will be evaluated objectively with the test of the computerized balance device planned to be applied. In this study, to in children with CP; "Modified Ashworth Scale" to evaluate spasticity in the hip, knee and ankle, "Gross Motor Function Classification System" to determine gross motor levels, "Trunk Control Measurement Scale" to measure dynamic and static balance, "Gross Motor Function Measure-88's sitting sub-test" to assess seating function", "Selective Control Assesment of Lower Extremity" to assess the selective motor control of the knee and ankle muscles, the sit to stand test of the computerized postural analysis device will be applied to assess the duration of the STS movement and the deviations during the movement. The application time of the tests varies between 5-30 minutes.
For typical developing children, all tests except the Modified Ashworth Scale and the Gross Motor Function Classification System will be applied from tests applied to children with CP.
This study will evaluate the independence of children with CP in daily life activities and contribute to the correct planning of rehabilitation goals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Patients with hemiplegic and diplegic cerebral palsy between 4 - 10 years of age |
| Control group | – | –Healthy volunteer typically developing peers |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- 16 spastic hemiplegic cerebral palsy patients, 12 spastic diplegic cerebral palsy patients between 4 - 10 years of age, and 32 healthy volunteer peers
Key inclusion criteria (6 listed)
- Confirmed diagnosis of spastic hemiplegic or diplegic cerebral palsy
- Age between 4 - 10
- Were having a level of 1 or 2 of GMFCS
- Able to stand without any orthosis or special equipment
- No orthopedic surgery or not having Botulinum Toxin-A injection in the last 6 months
Key exclusion criteria (3 listed)
- Having cognitive disorder
- Uncontrolled epilepsy
- Lower extremity contracture that may affect assessments
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
Trunk Control Measurement Scale (TCMS)
Time frame: Baseline
TCMS measures the state of balance on the support surface and the ability to actively move body parts during functional activities, which are the two components of trunk control. TCMS consists of 15 items in total that are scored on 2, 3 or 4 point ordinal scale and administered bilaterally in case of clinical relevance. The total TCMS score ranges from 0 to 58. A high score on this scale represents a better performance.
5 secondary outcomes
Selective Control Assessment of the Lower Extremity
Time frame: Baseline
Weight Transfer Time (sec) parameter of sit to stand test of Neurocome Balance Master
Time frame: Baseline
Rising Index (%) parameter of sit to stand test of Neurocome Balance Master
Time frame: Baseline
Sway Velocity (deg/sec)
Time frame: Baseline
Sitting domain of Gross Motor Function Measurement-88 (GMFM-88)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Results publication: PubMed 19220390Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.
- Results publication: PubMed 21757321Heyrman L, Molenaers G, Desloovere K, Verheyden G, De Cat J, Monbaliu E, Feys H. A clinical tool to measure trunk control in children with cerebral palsy: the Trunk Control Measurement Scale. Res Dev Disabil. 2011 Nov-Dec;32(6):2624-35. doi: 10.1016/j.ridd.2011.06.012. Epub 2011 Jul 14.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the principal investigator (DG). The data are not publicly available due to their containing information that could compromise the privacy of research participants.
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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.
Evrim Karadag Saygi, Prof study chair
Marmara 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 Cerebral Palsy, Spastic and Cerebral Palsy, Spastic, Diplegic, run by Marmara 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 6 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: status not confirmed, as of the sponsor's last update on 13 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Karadag Saygı, Prof (+902166570606162, evrim.saygi@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Control Measurement Scale (TCMS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225546, which also lists 2 linked publications.
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 13 Jan 2020.