Cerebral PalsyNCT06196944
Effects of Augmentative and Alternative Communication in Children With Cerebral Palsy Cerebral Palsy
A study testing Augmentative Alternative Communication and Augmentative Alternative Communication Device in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Augmentative Alternative Communication and Augmentative Alternative Communication Device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Aug 2023to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Augmentative and Alternative Communication in Children With Cerebral Palsy
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.
Read the 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 (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.
- Conditions
- Cerebral Palsy
- Being tested
- Augmentative Alternative Communication, Augmentative Alternative Communication Device
- Keywords
- Cerebral Palsy, Augmentative and Alternative Communication Devices, Speech and Language Therapy, Assisted Communication
- Medical subject headings
- Cerebral Palsy, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentative Alternative CommunicationBehavioural
Traditional Method
Augmentative Alternative Communication DeviceOther
Augmentative Alternative Communication Device 3 session for 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Augmentative Alternative Communication | Other | Traditional treatment Receives: Behavioral: Augmentative Alternative Communication |
| Augmentative Alternative Communication Device | Other | 3 sessions per week for 40 minutes Receives: Other: Augmentative Alternative Communication Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start8 Aug 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nazia Mumtaz, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196944
- Sponsor's protocol ID
- 2723 Sibgha
- Status last verified
- Jun 2024
- First submitted
- 26 Oct 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmentative and Alternative Communication in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06196944
- Acronym / sponsor ID
- 2723 Sibgha
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Augmentative and Alternative Communication Devices, Speech and Language Therapy, Assisted Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmentative Alternative Communication | Other | Behavioral: Augmentative Alternative CommunicationTraditional treatment |
| Augmentative Alternative Communication Device | Other | Other: Augmentative Alternative Communication Device3 sessions per week for 40 minutes |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmentative Alternative CommunicationTraditional Method | Behavioural | Augmentative Alternative Communication |
| Augmentative Alternative Communication DeviceAugmentative Alternative Communication Device 3 session for 40 minutes | Other | Augmentative Alternative Communication Device |
Primary outcome
Dysarthric Profile
Time frame: 16 weeks
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.
Picture Exchange Communication System (PECS)
Time frame: 16 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazia Mumtaz principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmentative Alternative Communication and Augmentative Alternative Communication Device in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysarthric Profile (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.