Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06196944 |
| Other study ID # |
2723 Sibgha |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 8, 2023 |
| Est. completion date |
November 28, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
Riphah International University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Communication abilities are basic developmental skills within the adaptive development of a
person, particularly during childhood. Therefore, children and teenagers with receptive and
expressive communication impairment face challenges over numerous life spans. Several kinds
of literature have detailed that they appear to have higher rates of psychosocial
disabilities, lower scholarly performance, more peer rejection, and troubles in their social
intelligence, compared to normal developing peers. Roughly 8% of children between the ages of
3 and 17 a long time within the United States face language and communication problems, and
thus may need extra support for normal communication skills. (1) Individual with complex
communication needs is likely to come from several different conditions (e.g., cerebral
palsy).
Even though some individuals with these challenges will be effectively supported by
assistance from other people, such as teachers, caregivers, community workers, and family
friends, there will be some who are underserved due to the lack of rehabilitation specialists
in low-income countries. (2) Cerebral Palsy has a neurogenic origin leading to physical
impairment in children or may be caused by maternal (perinatal, natal, and postnatal
injuries). The common types of cerebral palsy are spastic, flaccid, ataxic, or mixed types,
determined by the site of the lesion in the brain. It adversely affects gross and fine motor
development, receptive-expressive language skills, speech (articulation), voice (intensity,
pitch, and quality), and fluency, depending on etiology. (3) The prevalence of CP in the
United States ranges from 3-4 per 1000 live births.
Within the 2009-16 period, the prevalence of CP in children matured 3-17 a long time was 3.2
per 1000. The prevalence of low birth weight (LBW) and preterm in live births are altogether
higher (40-100/1000). According to a study in Swabi, Pakistan, the prevalence of CP is 1.22
per 1000 live births. However, country-wide statistics are not found but 6.9% incidence of CP
children admission in a Lahore hospital out of the 6.7% pediatric neurological admissions.
Research suggests evidence of the impact of the use of AAC-implemented intervention on 9
children in rural Kenya who have complex communication needs. The intervention used mainly
low- tech materials that were specifically designed to strengthen the child's communication
while remembering the caregiver's natural expertise. A pretest-posttest design was used in
this study. Data were gathered using an adapted version of the Communication Profile, which
was based on the International Classification of Functioning, Disability, and Health (ICF)
framework. Qualitative analysis was conducted in the final section of the study. The data
provided evidence of statistically significant positive changes in the communication of
children with cerebral palsy at the levels of Body Structure Function and Activities. Also,
the analysis revealed the positive perception of parents regarding AAC. (2) OBJECTIVE
To investigate the effects of Augmentative and Alternative Communication in Children with
Cerebral Palsy. HYPOTHESES NULL HYPOTHESIS Ho= Augmentative and alternative communication is
not an effective intervention for children with cerebral palsy.
ALTERNATE HYPOTHESIS H A =Augmentative and alternative communication is an effective
intervention for children with cerebral palsy. STUDY DESIGN Randomized Control trials
SETTING Rising Sun Institute for Special Children
DURATION OF THE STUDY 6 months after the approval of the synopsis
SAMPLE SIZE This sample is 16 according to the literature review. STUDY GROUPS Group A:
Treatment Group will consist of 8 children with cerebral palsy. Group B: Control Group will
consist of 8 children with cerebral palsy.
SAMPLING TECHNIQUE Simple Random Sampling Technique
DATA COLLECTION TOOL Dysarthric Profile will be used for assessment purposes and a low-tech
Picture Exchange Communication System (PECS) for the intervention.
DATA COLLECTION PROCEDURE:
According to the inclusion criteria, 16 children will be recruited. The children will be
assigned into groups. The randomly selected groups will be allocated 8 children as the
control group and 8 as the treatment/ interventional group. A pre-assessment of the child's
Early Functional development will be done. After that, the low-tech intervention will be
applied for 6 weeks (3 sessions per week for 40 minutes) to 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 be done. This indicates the effectiveness of AAC in
the communication of children with Cerebral Palsy.
