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Status unknownNCT04225546Updated Jan 13, 2020

Sit to Stand Movement in Children With Cerebral Palsy

An observational study in Cerebral Palsy, Spastic and Cerebral Palsy, Spastic, Diplegic, sponsored by Marmara University. Status unknown at 1 site in Turkey. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Marmara University · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
32
Ages
4 Years to 10 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cerebral Palsy, Spastic
  • Cerebral Palsy, Spastic, Diplegic

Keywords

  • cerebral palsy
  • selective control
  • trunk
  • sit to stand
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 32 is below the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
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

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

Exclusion Criteria:

  1. Having cognitive disorder
  2. Uncontrolled epilepsy
  3. Lower extremity contracture that may affect assessments
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
32 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Patient group

    Patients with hemiplegic and diplegic cerebral palsy between 4 - 10 years of age

  • Control group

    Healthy volunteer typically developing peers

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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

    Time frame: Baseline

07

Study locations

1 site
  • Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
    Istanbul, 34899, Turkey
08

References and documents

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 19220390 ↗
  • 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. PubMed 21757321 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04225546
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Jan 4, 2020 (estimated)
Primary completion
Mar 4, 2020 (estimated)
Completion
Mar 15, 2020 (estimated)
Last update
Jan 13, 2020

Study contacts

Esra Karadag Saygı, Prof
Contact
evrim.saygi@marmara.edu.tr
+902166570606162
Esra Giray, MD
Contact
girayesra@hotmail.com
+905558134394
Evrim Karadag Saygi, Prof
study chair · Marmara University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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