NCT03179124

Brief Summary

Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Poor postural control restricts upper extremity functions which also affects the quality of movements. For this reason, it is important to assess the relationship between trunk control and upper extremity functions. This study is planned to investigate the effect of balance and trunk control on upper extremity functions in children with CP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

June 6, 2017

Last Update Submit

June 6, 2017

Conditions

Keywords

cerebral palsytrunk controlupper extremity

Outcome Measures

Primary Outcomes (1)

  • Quality of Upper Extremity Skills Test

    QUEST is a reliable tool for children with CP aged 2-12 years.The QUEST groups upper limb movement into four domains. Each domain focuses on areas of difficulty typically seen in children with spastic cerebral palsy: (a) Dissociated Movements, (ability to voluntarily isolate movement at the shoulder, elbow, wrist and fingers); (b) Grasps (which also rates sitting postures during grasps of 1 inch cube, cereal, pencil or crayon); (c) Weight Bearing (ability to lean on the arms in prone or 4-point kneeling, sitting and while reaching); and (d) Protective Extension (using the arms to stop oneself from falling forward, backward and to the side). In addition to the four domains of movement the QUEST also has three scales: Hand Function, Spasticity and Co-operativeness.

    30 minutes

Secondary Outcomes (2)

  • Pediatric Balance Scale

    20 minutes

  • Trunk Control Measurement Scale

    20 minutes

Study Arms (2)

Hemiparetic cerebral palsy

Unilateral paresis in which upper extremities are more severely affected than lower extremities.

Diparetic cerebral palsy

Lower extremities were more affected than upper extremities

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Cerebral palsy (CP) describes a group of permanent disorders in movement and posture that limit activity and participation and are attributed to non-progressive disturbances in the developing fetal or infant brain

You may qualify if:

  • spastic hemiparetic and / or diparetic CP
  • co-operative enough to understand test directives
  • between 5 and 12 years of age
  • Having spasticity of 0-2 according to the modified wax and / or modified Ashworth Scale (MAS)
  • GMFCS I, II and III

You may not qualify if:

  • Have had previous orthopedic surgery to the upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bülent Elbasan

    study chair

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 7, 2017

Study Start

June 20, 2016

Primary Completion

April 20, 2017

Study Completion

May 20, 2017

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share