NCT06196944

Brief Summary

Cerebral Palsy is a neuromuscular disorder that causes multiple disabilities in an individual. Children's ability to rely on speech as a primary mode of communication can be compromised by cerebral palsy. Children with communication difficulties face many barriers to participating in everyday life and have a heightened risk of social isolation and mental health problems. So, augmentative, and alternative communication (AAC) strategies and tools are helpful for children with CP. AAC is classified into manual signs and symbols, and low, mid, and high- tech communication aids form part of a total communication approach whereby all potential modalities of communication are explored and supported. The World Health Organization International Classification of Function, Disability, and Health for Children and Youth is increasingly being used to support decision-making. The study will be carried out at Rising Sun Institute for Special Children. The study design for this study is Randomized Control Trials. The convenience Sampling Technique will be used to collect data and 16 children with cerebral palsy will be included in this study. Both males and females with the age range of 3-15 years will be included in this study. The children will be randomly assigned into groups, group A will be allocated 8 children as the control group, and in group B, 8 as the treatment/ interventional group. Dysarthric Profile will be used for assessment purposes and aided Augmentative and Alternative communication system for the intervention. The pre-assessment of the child's Early Functional development will be done. Then, the low- tech (PECS) will be used for 6 weeks for the intervention. We will take 3 sessions per week for 40 minutes for the treatment group while the control group will remain the same. After the end of 6 weeks, the post-assessment of the child's Early Functional development will also be done. This indicates the effectiveness of AAC devices in the communication of children with Cerebral Palsy. The use of AAC methods could help to reduce aggressiveness among children with cerebral palsy. Moreover, AAC-based information and tools enable them to create environments that will support or enhance the ability of people with complex communication needs to interact with family members, peers, teachers, and others.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

October 26, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

Cerebral PalsyAugmentative and Alternative Communication DevicesSpeech and Language TherapyAssisted Communication

Outcome Measures

Primary Outcomes (2)

  • Dysarthric Profile

    Dysarthria Rating Scale Rate speech by assigning a value of 0-4 to each of the dimensions listed below (0 = normal; 1 mild; 2 moderate; 3 marked; 4 severely deviant). A + should be used to indicate excessive or high; - should be used to indicate reduced or low when appropriate.

    16 weeks

  • Picture Exchange Communication System (PECS)

    The Picture Exchange Communication System (PECS) is a way for autistic people to communicate without relying on speech. To communicate, people use cards with pictures, symbols, words or photographs to ask for things, comment on things or answer questions.

    16 weeks

Study Arms (2)

Augmentative Alternative Communication

OTHER

Traditional treatment

Behavioral: Augmentative Alternative Communication

Augmentative Alternative Communication Device

OTHER

3 sessions per week for 40 minutes

Other: Augmentative Alternative Communication Device

Interventions

Traditional Method

Augmentative Alternative Communication

Augmentative Alternative Communication Device 3 session for 40 minutes

Augmentative Alternative Communication Device

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Both male and female children who have a confirmed diagnosis of cerebral palsy as reported in the medical history by a medical specialist (i.e., neurologist, pediatrician)

You may not qualify if:

  • No child will be with any kind of comorbidity symptoms or any known additional disabilities (e.g., Down syndrome, autism spectrum disorder, seizure disorder, blindness, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sibgha Shafique

Lahore, Punjab Province, 54920, Pakistan

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 Officials

  • Nazia Mumtaz

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

January 9, 2024

Study Start

August 8, 2023

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations