Clinical trial NCT04225546: Sit to Stand Movement in Children With Cerebral Palsy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy, Spastic
Cerebral Palsy, Spastic, Diplegic
Keywords: cerebral palsy
selective control
trunk
sit to stand
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of spastic hemiplegic or diplegic cerebral palsy
2. Age between 4 - 10
3. Were having a level of 1 or 2 of GMFCS
4. Able to stand without any orthosis or special equipment
5. No orthopedic surgery or not having Botulinum Toxin-A injection in the last 6 months
6. Volunteer to study

Exclusion Criteria:

1. Having cognitive disorder
2. Uncontrolled epilepsy
3. Lower extremity contracture that may affect assessments

Primary outcomes:
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: Baseline
Secondary outcomes:
measure: Selective Control Assessment of the Lower Extremity
timeFrame: Baseline
measure: Weight Transfer Time (sec) parameter of sit to stand test of Neurocome Balance Master
timeFrame: Baseline
measure: Rising Index (%) parameter of sit to stand test of Neurocome Balance Master
timeFrame: Baseline
measure: Sway Velocity (deg/sec)
timeFrame: Baseline
measure: Sitting domain of Gross Motor Function Measurement-88 (GMFM-88)
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: Evrim Karadag Saygi, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.