NCT06591689

Brief Summary

Communication problems are frequently encountered in quadriparetic cerebral palsy. Additionally, motor impairments often accompany this condition. Communication problems can also reduce the benefits gained from treatments, which in turn negatively affects individuals functional independence as motor impairments persist. In this study, the researchers aimed to examine the relationship between communication function, gross motor function and functional independence level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 years

First QC Date

September 7, 2024

Last Update Submit

September 12, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Communication Function Classification System (CFCS)

    The communication functions of patients were evaluated using the "Communication Function Classification System (CFCS)." CFCS assesses the daily communication performance of individuals with cerebral palsy (CP) across five levels. It evaluates all methods that affect communication performance, such as speech, facial expressions, gestures, eye contact, facial cues, and the use of augmentative and alternative communication methods. In CFCS, Level I indicates a better condition, while Level V represents more impaired situations.

    1 month

  • The Pediatric Functional Independence Measure (WeeFIM)

    The Pediatric Functional Independence Measure (WeeFIM) is a useful, brief, and comprehensive assessment method for identifying the functional limitations of children with developmental disorders. It consists of 18 items under the categories of self-care, sphincter control, transfers, mobility, communication, and social interaction. Each item is scored between 1 and 7. A child receives a score of 1 when performing an item with full assistance, and a score of 7 when completing it independently, safely, and in a timely manner. Afterwards, all scores are summed to calculate a percentage of independence. The WeeFIM assessments were carried out by physiotherapists based on information obtained from families. High scores on this scale indicate a high level of independence.

    1 month

  • The Gross Motor Function Measure-88 (GMFM-88)

    The Gross Motor Function Measure-88 (GMFM-88) was used to determine the functional performance of children. GMFM-88 is a standardized, validated observational scale, and it is mandatory to use the user manual for scoring each item. GMFM-88 evaluates five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking. Each section is assessed individually, and a percentage score is calculated. The total score is obtained by averaging the percentage scores of the five sections. The items in the sections are scored as 0, 1, 2, or 3. The GMFM-88 scores were calculated by physiotherapists in strict adherence to the user manual. Total GMFM-88 score is evaluated out of 100, and higher scores indicate good gross motor development.

    1 month

Interventions

20 quadriparetic cerebral palsy cases were evaluated with the Communication Function Classification System (CFCS), Pediatric Functional Independence Scale (WeeFIM) and Gross Motor Function Measure-88 (GMFM-88).

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Twenty quadriparetic cerebral palsy individuals between the ages of 0-17 were included in the study.

You may qualify if:

  • Ages between 0-17,
  • Diagnosed with quadriparetic cerebral palsy,
  • Participants and parents willing to participate in the study voluntarily.

You may not qualify if:

  • Having different types of cerebral palsy such as dyskinetic, ataxic and mixed type,
  • Having spastic diparetic or hemiparetic type cerebral palsy,
  • Having any history of surgery on the musculoskeletal system,
  • Having received Botulinum Toxin injections in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyCommunication Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

September 7, 2024

First Posted

September 19, 2024

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

August 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations