NCT03417726

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

January 11, 2018

Last Update Submit

December 8, 2018

Conditions

Cerebral Palsy, SpasticBalance; Distorted

Keywords

Cerebral PalsyBalance

Outcome Measures

Primary Outcomes (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.

    2 min

Secondary Outcomes (8)

  • Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Firm-Eyes Closed, Foam-Eyes Open, Foam-Eyes Closed

    3 min

  • Limits of Stability (LOS)

    2 min

  • Walk Across (WA)

    5 min

  • Tandem Walk (TW)

    5 min

  • Unilateral Stance (US)

    5 min

  • +3 more secondary outcomes

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Spastic Cerebral Palsy

You may qualify if:

  • 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

You may not qualify if:

  • Visual and vestibular deficits
  • Severe scoliosis (Cobb angle \>40°)
  • Uncontrolled seizures (Seizure in previous 6 months)
  • Having intrathecal baclofen pump
  • Having undergone selective dorsal rhizotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • 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.

    PMID: 17057441BACKGROUND

  • 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.

    PMID: 19220390BACKGROUND

  • 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.

    PMID: 17370477BACKGROUND

  • 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.

    PMID: 23679987BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Naime Evrim Karadag Saygi, Prof

    Marmara University School of Medicine, Pendik Research and Training Hospital, Department of Physical Medicine and Rehabilitation, Istanbul / Turkey 34890

    STUDY CHAIR

Central Study Contacts

Duygu G Karali Bingul, MD

CONTACT

00905353212887d_karali@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 31, 2018

Study Start

January 1, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

TU(1)