- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04225546
Sit to Stand Movement in Children With Cerebral Palsy
Relationship Between Sit to Stand Movement, Trunk Control and Selective Motor Control of Lower Extremity in Children With Hemiplegic and Diplegic Cerebral Palsy
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Esra Karadag Saygı, Prof
- Phone Number: +902166570606162
- Email: evrim.saygi@marmara.edu.tr
Study Locations
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Istanbul, Turkey, 34899
- Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having cognitive disorder
- Uncontrolled epilepsy
- Lower extremity contracture that may affect assessments
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patient group
Patients with hemiplegic and diplegic cerebral palsy between 4 - 10 years of age
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Control group
Healthy volunteer typically developing peers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Trunk Control Measurement Scale (TCMS)
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Selective Control Assessment of the Lower Extremity
Time Frame: Baseline
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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.
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Baseline
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Weight Transfer Time (sec) parameter of sit to stand test of Neurocome Balance Master
Time Frame: Baseline
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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.
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Baseline
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Rising Index (%) parameter of sit to stand test of Neurocome Balance Master
Time Frame: Baseline
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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.
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Baseline
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Sway Velocity (deg/sec)
Time Frame: Baseline
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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.
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Baseline
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Sitting domain of Gross Motor Function Measurement-88 (GMFM-88)
Time Frame: Baseline
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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
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Heyrman 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2019.261
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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