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).
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.
Turkey (Türkiye)1 site, 1 recruiting
- 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
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.
- Conditions
- Cerebral Palsy, Spastic, Balance; Distorted
- 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.
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)
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
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
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
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
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
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
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
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.
- First posted31 Jan 2018
- Study start1 Jan 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naime Evrim Karadag Saygi, Prof, Study chair, Marmara University School of Medicine, Pendik Research and Training Hospital, Department of Physical Medicine and Rehabilitation, Istanbul / Turkey 34890
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 17057441Fowler 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 19220390Rosenbaum 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 17370477Saether 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Pediatric Balance Scale and Quantitative Balance Parameters in Patients With Cerebral Palsy"
- ClinicalTrials.gov ID
- NCT03417726
- Acronym / sponsor ID
- 09.2017.735
- Conditions
- Cerebral Palsy, Spastic, Balance; Distorted
- Keywords
- Cerebral Palsy, Balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Spastic Cerebral Palsy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Open
Time frame: 2 min
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.
8 secondary outcomes
Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Closed, Foam-Eyes Open, Foam-Eyes Closed
Time frame: 3 min
Limits of Stability (LOS)
Time frame: 2 min
Walk Across (WA)
Time frame: 5 min
Tandem Walk (TW)
Time frame: 5 min
Unilateral Stance (US)
Time frame: 5 min
Step/Quick Turn (SQT)
Time frame: 5 min
Pediatric Balance Scale (PBS)
Time frame: 20 min
Selective Control Assessment of the Lower Extremity (SCALE)
Time frame: 15 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Background: PubMed 17057441Franjoine 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.
- Background: PubMed 19220390Fowler 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.
- Background: PubMed 17370477Rosenbaum 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.
- Background: PubMed 23679987Saether 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.
Related trials for Cerebral Palsy, Spastic
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naime Evrim Karadag Saygi, Prof study chair
Marmara University School of Medicine, Pendik Research and Training Hospital, Department of Physical Medicine and Rehabilitation, Istanbul / Turkey 34890
1 site in 1 country: see every site and its status.
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.