Cerebral PalsyNCT01948154
The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study
An observational study of Cerebral Palsy and Speech Function, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Speech Function, Quality of Life
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2013to Dec 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: We will have children with CP (n=60~80) and normal (n=50) from 2-12 years old under consent of their family.
Who may be able to join
- Parents or guardians who signed informed consent
- Age 6-12 year old
- Diagnosed to have cerebral palsy
Who cannot join
- Concurrent medical condition (such as: seizure, infection)
- Surgery within 3 months
- Botulinum toxin-A injection within 3 months
- Concurrent progressive or degenerative diseases, peripheral neuropathy, spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).
Read the detailed description
Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).
The investigators study aim in this project include: (1) to find the differences in speech function in normal developed children and in children with CP with different severity; (2) the relationship between speech function and QoL in children with CP; (3) to seek the predictable factor involving motor speech function in children with CP from the framework of International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY).
This will be a 3-year longitudinal project recruiting 110-130 children in total. The investigators will have children with CP (n=60~80) and normal (n=50) from 2-12 years old under consent of their family. The investigator's study will be based on structure of ICF-CY. In the first year, basic clinical assessments including motor, mental, vocabulary, motor speech function, general development, and subjective questionnaires on adaptation, participation, development and quality of life will be collected. During the second to the third year, all measurements will be repeated in the end of 6- and 12-month to follow the performance of children with CP and those with normal development.
The anticipated outcomes of this study are: (1) to observe the longitudinal change of speech function and QoL in children with CP. (2) Using ICF-CY items in rehabilitation services to describe the speech function and participation of social life for children with CP. (3)To identify the influencing factors and predictors of motor speech function for children with CP.
- Conditions
- Cerebral Palsy, Speech Function, Quality of Life
- Keywords
- Cerebral Palsy, Early Intervention, Speech Function, Quality of Life
- Medical subject headings
- Cerebral Palsy, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children with CP | Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. 2-12 years old (n=60-80) | |
| normal child | normal child 2-12 years old (50 subjects) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up
change of CDIIT
Measured: baseline, 6 month, 12 month
Secondary outcomes (1)
change of Mental Ability
change of Mental Ability (BSID-II, WPPSI-R, WISC-IV)in 6 month, 12 month follow up
Measured: baseline, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2017
- Study completionDec 2017
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 Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie P Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948154
- Sponsor's protocol ID
- CMRPG3C1241
- Status last verified
- Jan 2018
- First submitted
- 5 Sep 2013
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Speech Function and Quality of Life in Children With Cerebral Palsy: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT01948154
- Acronym / sponsor ID
- CMRPG3C1241
- Conditions
- Cerebral Palsy, Speech Function, Quality of Life
- Keywords
- Cerebral Palsy, Early Intervention, Speech Function, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Sep 2013 (estimated)
- 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 (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).
Detailed description
Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. It is not infrequently to note concurrent impairment in sensory, intelligence, vision and auditory in those patients. Many studies have documented Cerebral palsy is associated with a variety of neuromotor disorders that frequently affect the speech production system. The speech function impairment varied widely due to different severity of diseases involved. The investigators hypothesize such impairment of speech function may affect degree of social participation and eventually the quality of life (QoL).
The investigators study aim in this project include: (1) to find the differences in speech function in normal developed children and in children with CP with different severity; (2) the relationship between speech function and QoL in children with CP; (3) to seek the predictable factor involving motor speech function in children with CP from the framework of International Classification of Functioning, Disability and Health - Children and Youth Version (ICF-CY).
This will be a 3-year longitudinal project recruiting 110-130 children in total. The investigators will have children with CP (n=60~80) and normal (n=50) from 2-12 years old under consent of their family. The investigator's study will be based on structure of ICF-CY. In the first year, basic clinical assessments including motor, mental, vocabulary, motor speech function, general development, and subjective questionnaires on adaptation, participation, development and quality of life will be collected. During the second to the third year, all measurements will be repeated in the end of 6- and 12-month to follow the performance of children with CP and those with normal development.
The anticipated outcomes of this study are: (1) to observe the longitudinal change of speech function and QoL in children with CP. (2) Using ICF-CY items in rehabilitation services to describe the speech function and participation of social life for children with CP. (3)To identify the influencing factors and predictors of motor speech function for children with CP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with CP | – | –Cerebral palsy (CP) encompass a group of non-progressive, non-contagious motor conditions that cause physical disability in human development. 2-12 years old (n=60-80) |
| normal child | – | –normal child 2-12 years old (50 subjects) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We will have children with CP (n=60~80) and normal (n=50) from 2-12 years old under consent of their family.
Key inclusion criteria (3 listed)
- Parents or guardians who signed informed consent
- Age 6-12 year old
- Diagnosed to have cerebral palsy
Key exclusion criteria (4 listed)
- Concurrent medical condition (such as: seizure, infection)
- Surgery within 3 months
- Botulinum toxin-A injection within 3 months
- Concurrent progressive or degenerative diseases, peripheral neuropathy, spinal cord injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up
Time frame: baseline, 6 month, 12 month
change of CDIIT
1 secondary outcome
change of Mental Ability
Time frame: baseline, 6 month, 12 month
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 30 Jan 2018.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
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.
Katie P Wu, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Speech Function, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 30 Jan 2018. 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 Taiwan. 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?
change in General Developmental Assessment (CDIIT) in 6 month and 12 month follow up (time frame: baseline, 6 month, 12 month). 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 30 Jan 2018; AzTrials last refreshed its copy on 7 Nov 2026.