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Cerebral Palsy, SpasticNCT03417726

Evaluation of Pediatric Balance Scale and Quantitative Balance Parameters in Patients With Cerebral Palsy

An observational study of Cerebral Palsy, Spastic and Balance; Distorted, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate Pediatric Balance Scale and quantitative balance and gait parameters assessed by Balance Master force plate in Cerebral Palsy (CP) patients who are ambulatory without an assistive device in daily life. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Cerebral Palsy, Spastic, Balance; Distorted
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 1 Jun 2019
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients with Spastic Cerebral Palsy

Who may be able to join

  • Patients diagnosed with spastic cerebral palsy
  • Age between 4-18 years
  • Sufficient cooperation to understand instructions and participate evaluations
  • Gross Motor Function Classification System (GMFCS) level I-II
  • Giving an informed consent

Who cannot join

  • Visual and vestibular deficits
  • Botulinum-toxin A treatment within 3 months or having undergone an orthopaedic surgery 1 year prior to inclusion in the study
  • Severe scoliosis (Cobb angle >40°)
  • Uncontrolled seizures (Seizure in previous 6 months)
  • Having intrathecal baclofen pump
  • Having undergone selective dorsal rhizotomy

Trial locations and contacts

1 site in 1 country.

Duygu G Karali Bingul, MD contact

00905353212887

d_karali@yahoo.com

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

    Istanbul, 34890

    Duygu G Karali Bingul, MD, 00905353212887, d_karali@yahoo.com

    Duygu G Karali Bingul, MD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: "Evaluation of Pediatric Balance Scale and Quantitative Balance Parameters in Patients With Cerebral Palsy"

This study aims to evaluate Pediatric Balance Scale and quantitative balance and gait parameters assessed by Balance Master force plate in Cerebral Palsy (CP) patients who are ambulatory without an assistive device in daily life.

Read the detailed description

CP refers to a group of motion and posture disorders that limit activity and participation which is attributed to non-progressive disturbances in the developing fetus or infant brain. In CP, motor and sensory disorders are often accompanied by poor balance control. Impaired balance control leads to increased risk of falling, which is a major kinesiologic problem in children who are ambulatory without an assistive device.

Functional balance in children is defined as the ability to maintain the center of gravity according to the base of support during typical childhood activities of daily living, school and play. The Pediatric Balance Scale, a modification of the Berg Balance Scale, was developed as a functional balance measure for children, easily administered without specialized equipment in a relatively short time.

Balance Master® (Neurocom International Clackmas, Oregon, USA) is a device consisting of a system that processes signals from an 18x60 inch plaque that transmits the vertical forces exerted through patient's feet to measure center of gravity position and postural control through a software program.

The aim of this study is to compare PBS results with quantitative balance and gait parameters obtained from Balance Master in spastic CP patients who are independently ambulatory. The level of correlation between these measurement methods will be examined and superiority to each other in assessing balance problems in this patient group will be evaluated.

Keywords
Cerebral Palsy, Balance
Medical subject headings
Cerebral Palsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Open

    Evaluations will be done by Balance Master® (Neurocom International Clackmas, Oregon, USA) device which consists a system that processes signals from an 18x60 inch plaque that transmits the vertical forces exerted through patient's feet to measure center of gravity (COG) position and postural control through a software program. Each assessment will be made 3 times and average scores will be calculated via program.

    Mean COG Sway Velocity (deg/sec) during standing on a Firm Surface-Eyes Open is the primary outcome measure.

    Measured: 2 min

Secondary outcomes (8)
  1. Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Closed, Foam-Eyes Open, Foam-Eyes Closed

    Evaluations will be done by Balance Master® (Neurocom International Clackmas, Oregon, USA) device which consists a system that processes signals from an 18x60 inch plaque that transmits the vertical forces exerted through patient's feet to measure center of gravity position and postural control through a software program. Each assessment will be made 3 times and average scores will be calculated via program.

    Mean COG Sway Velocity (deg/sec) and COG Alignment during 3 sensory conditions will be assessed as secondary outcome measures: Firm-Eyes Closed, Foam-Eyes Open, Foam-Eyes Closed.

    Measured: 3 min

  2. Limits of Stability (LOS)

    Evaluations will be done by Balance Master® device. Reaction Time (sec), Movement Velocity (deg/sec), Endpoint Excursions (%), Max Excursions (%) and Directional Control (%) will be recorded during forward leaning.

    Measured: 2 min

  3. Walk Across (WA)

    Evaluations will be done by Balance Master® device. Gait parameters; Step Width (cm), Step Length (cm), Speed (cm/sec), Step Length Symmetry (%) will be recorded while walking across the forceplate. Each assessment will be made 3 times and average scores will be calculated via program.

    Measured: 5 min

  4. Tandem Walk (TW)

    Evaluations will be done by Balance Master® device. Step Width (cm), Speed (cm/sec), End Sway (deg/sec) will be recorded as the patient walks heel to toe from one end of the forceplate to the other as quickly as possible and then stop. Each assessment will be made 3 times and average scores will be calculated via program.

    Measured: 5 min

  5. Unilateral Stance (US)

    Evaluations will be done by Balance Master® device. Mean COG Sway Velocity (deg/sec) will be recorded during left and right single leg standing while eyes open. Each assessment will be made 3 times and average scores will be calculated via program.

    Measured: 5 min

  6. Step/Quick Turn (SQT)

    Evaluations will be done by Balance Master® device. Turn Time (sec), Turn Sway (deg), Left/Right Turn Time Difference (%) and Left/Right Turn Sway Difference (%) will be recorded as the patient walks from one end of the forceplate to the other, take a quick 180 degrees turn to either left or right and return to the starting point. Each assessment will be made 3 times and average scores will be calculated via program.

    Measured: 5 min

  7. Pediatric Balance Scale (PBS)

    PBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS has been used initially to measure the balance functions for school-age children with mild-to-moderate motor impairments. A recent study has shown that PBS is also sensitive in assessing functional balance differences in children aged 4-10 with a rough motor function classification system (KMFSS) level 1-2

    The PBS is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The highest score in PBS is 56.

    Measured: 20 min

  8. Selective Control Assessment of the Lower Extremity (SCALE)

    The SCALE tool was designed for clinical administration and scoring by healthcare professionals, to be used in less than 15 minutes without specialized equipment. The tool includes 'Directions for Administration,' 'Instructions for Grading,' and a 'Score Sheet.' Hip, knee, ankle, subtalar, and toe joints are assessed bilaterally. The following factors were used to develop the assessment and grading criteria: (1) ability to move each joint selectively; (2) involuntary movement at other joints including the contralateral limb; (3) ability to reciprocate movement; (4) speed of movement; and (5) generation of force as demonstrated by excursion within the available range of motion. Selective voluntary motor control is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).

    Measured: 15 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2018
  2. Study start1 Jan 2018
  3. Primary completion1 Mar 2019 (estimated)
  4. Study completion1 Jun 2019 (estimated)

Resources

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
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03417726
Sponsor's protocol ID
09.2017.735
Status last verified
Dec 2018
First submitted
11 Jan 2018
Last updated
11 Dec 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.

    PubMed 17057441
  • 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
  • Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

    PubMed 17370477
  • Saether R, Helbostad JL, Riphagen II, Vik T. Clinical tools to assess balance in children and adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2013 Nov;55(11):988-99. doi: 10.1111/dmcn.12162. Epub 2013 May 16.

    PubMed 23679987

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, Spastic and Balance; Distorted, 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 5 inclusion and 6 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 11 Dec 2018. 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 Duygu G Karali Bingul, MD (00905353212887, d_karali@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Open (time frame: 2 min). 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 NCT03417726, which also lists 4 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 11 Dec 2018.

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