Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196944
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-10-26
Brief Title:
Effects of Augmentative and Alternative Communication in Children With Cerebral Palsy Cerebral Palsy
Sponsor:
Riphah International University
Organization:
Riphah International University
Study Overview
Official Title:
Effects of Augmentative and Alternative Communication in Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cerebral Palsy is a neuromuscular disorder that causes multiple disabilities in an individual
Childrens 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 childs 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 childs 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
Childrens 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 childs 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 childs 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
Detailed 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 eg 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 32 per 1000 The prevalence of low birth weight LBW and preterm in live births are altogether higher 40-1001000 According to a study in Swabi Pakistan the prevalence of CP is 122 per 1000 live births However country-wide statistics are not found but 69 incidence of CP children admission in a Lahore hospital out of the 67 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 childs communication while remembering the caregivers 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 childs 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 childs Early Functional development will be done This indicates the effectiveness of AAC in the communication of children with 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 32 per 1000 The prevalence of low birth weight LBW and preterm in live births are altogether higher 40-1001000 According to a study in Swabi Pakistan the prevalence of CP is 122 per 1000 live births However country-wide statistics are not found but 69 incidence of CP children admission in a Lahore hospital out of the 67 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 childs communication while remembering the caregivers 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 childs 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 childs Early Functional development will be done This indicates the effectiveness of AAC in the communication of children with Cerebral Palsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None