Sit to Stand Movement in Children With Cerebral Palsy

Cerebral Palsy, Spastic Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04225546
• Other study ID #: 09.2019.261
• Status: Not yet recruiting
• Start date: January 4, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: January 2020
• Source: Marmara University
• Contact: Esra Karadag Saygi, Prof
• Phone: +902166570606162
• Email: evrim.saygi[@]marmara.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 15, 2020
• Est. primary completion date: March 4, 2020
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Cerebral Palsy, Spastic, Diplegic
• Muscle Spasticity
• Paralysis

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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):60 — View 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.rid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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	Baseline