Cerebral PalsyAPCPNCT01217242
Activity and Participation in Ambulatory Cerebral Palsy
An observational study of Cerebral Palsy, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The investigators would like to understand how the physical activity levels and body size of a child with cerebral palsy (CP) in a clinical situations versus out in the community relates to what they want to do in day to day life (participation in life). Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2011
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk
Who may be able to join
- age 2 to <10 years (30 per four age groups/2 year increments)
- Gross Motor Function Classification System (GMFCS) levels I-III
- diagnosis of cerebral palsy (CP) or developmental movement disorder that occurred prior to age two.
Who cannot join
- visual impairment limiting physical activity
- lower extremity botox injections in the last 3 months
- uncontrolled seizure disorder impacting mobility skills
- orthopedic or neurosurgery in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98101
About this study
Official title: Cross-sectional Descriptive Study to Quantify to What Extent Activity Capacity, Performance and Body Composition Predict Day to Day Life Participation in Ambulatory Children With CP.
The investigators would like to understand how the physical activity levels and body size of a child with cerebral palsy (CP) in a clinical situations versus out in the community relates to what they want to do in day to day life (participation in life). The investigators believe that what a child really does out in day to day life will predict life participation to a greater degree than what they do in a structured clinical situation (i.e. therapy session with therapist). The investigators think that increased body size with normal growth is related to less physical activity and participation in day to day life for children with cerebral palsy (CP) who can walk. This project will use a novel accelerometer to measure walking activity during day to day life.
Read the detailed description
We want to know how the physical activity of children with walking problems or cerebral palsy (CP) relates to what they do in their day to day lives.
We are looking for children who:
- Have walking problems that started before age 2
- Have any type of cerebral palsy (CP) or primary problem that is a developmental movement disorder
- May have hemiplegia, diplegia, walking quadriplegia, May have ataxia, spastic, mixed tone, athetoid, or dyskinetic
- Ages 2 years to less than 10 years
- Able to do some functional walking with or without help(walkers, gait trainers)
- Project requires a one time visit to Seattle Children's Hospital of about 2 hours.
- Children and/or parents will complete surveys.
- The child will be tested for their gross motor and walking skills like at a physical therapy session.
- The child will be given an ankle monitor to wear for 7-10 days.
- They will return the monitor by mail with a questionnaire about what they did the last week.
- Families will receive a print out of their child's walking activity
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, walking activity, physical activity, participation, activity performance, activity capacity
- Medical subject headings
- Cerebral Palsy, Motor Activity
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 cerebral palsy (CP) | ages 2 to < 10 years who are able to walk with or without an assistive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community walking activity with the STEPWATCH accelerometer
Walking activity performance within the context of daily life will be measured with a monitor called the StepWatch. The StepWatch was specifically designed and validated for long-term assessment of ambulatory activity during day-to-day life. It is a small,waterproof, self-contained device that is worn on the ankle. It records the number of strides taken every minute for up to two months between downloads.
Measured: Assessed at one time point with a 7-10 walking sample
Secondary outcomes (1)
Participation in day to day life activities
Participation will be quantified by two valid measures of pediatric life participation, the Children's Assessment of Participation and Enjoyment (CAPE) and the Assessment of Life Habits (Life-H for Children).The CAPE was designed to document the child's report of participation in day to day activities, while the Life-H for children is intended to describe a group of life habits that are characteristic of children in their environment (home, school and neighborhood).
Measured: Assessed as one time point by parental/child report of participation in the last 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionDec 2011
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 Seattle Children's 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kristie Bjornson, Seattle Children's Hospital
- Investigators
- Carol Nicholson, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217242
- Sponsor's protocol ID
- K23HD060764
- Other IDs
- K23HD060764
- Acronym
- APCP
- Status last verified
- Jan 2012
- First submitted
- 4 Oct 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Descriptive Study to Quantify to What Extent Activity Capacity, Performance and Body Composition Predict Day to Day Life Participation in Ambulatory Children With CP.
- ClinicalTrials.gov ID
- NCT01217242
- Acronym / sponsor ID
- APCP / K23HD060764
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, walking activity, physical activity, participation, activity performance, activity capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Oct 2010 (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.
The investigators would like to understand how the physical activity levels and body size of a child with cerebral palsy (CP) in a clinical situations versus out in the community relates to what they want to do in day to day life (participation in life). The investigators believe that what a child really does out in day to day life will predict life participation to a greater degree than what they do in a structured clinical situation (i.e. therapy session with therapist). The investigators think that increased body size with normal growth is related to less physical activity and participation in day to day life for children with cerebral palsy (CP) who can walk. This project will use a novel accelerometer to measure walking activity during day to day life.
Detailed description
We want to know how the physical activity of children with walking problems or cerebral palsy (CP) relates to what they do in their day to day lives.
We are looking for children who:
- Have walking problems that started before age 2
- Have any type of cerebral palsy (CP) or primary problem that is a developmental movement disorder
- May have hemiplegia, diplegia, walking quadriplegia, May have ataxia, spastic, mixed tone, athetoid, or dyskinetic
- Ages 2 years to less than 10 years
- Able to do some functional walking with or without help(walkers, gait trainers)
- Project requires a one time visit to Seattle Children's Hospital of about 2 hours.
- Children and/or parents will complete surveys.
- The child will be tested for their gross motor and walking skills like at a physical therapy session.
- The child will be given an ankle monitor to wear for 7-10 days.
- They will return the monitor by mail with a questionnaire about what they did the last week.
- Families will receive a print out of their child's walking activity
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy (CP) | – | –ages 2 to < 10 years who are able to walk with or without an assistive device |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cerebral palsy (CP) or developmental movement disorder before age two who are able to walk
Key inclusion criteria (3 listed)
- age 2 to <10 years (30 per four age groups/2 year increments)
- Gross Motor Function Classification System (GMFCS) levels I-III
- diagnosis of cerebral palsy (CP) or developmental movement disorder that occurred prior to age two.
Key exclusion criteria (4 listed)
- visual impairment limiting physical activity
- lower extremity botox injections in the last 3 months
- uncontrolled seizure disorder impacting mobility skills
- orthopedic or neurosurgery in the last 6 months.
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
Community walking activity with the STEPWATCH accelerometer
Time frame: Assessed at one time point with a 7-10 walking sample
Walking activity performance within the context of daily life will be measured with a monitor called the StepWatch. The StepWatch was specifically designed and validated for long-term assessment of ambulatory activity during day-to-day life. It is a small,waterproof, self-contained device that is worn on the ankle. It records the number of strides taken every minute for up to two months between downloads.
1 secondary outcome
Participation in day to day life activities
Time frame: Assessed as one time point by parental/child report of participation in the last 4 months
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 5 Jan 2012.
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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.
Carol Nicholson, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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, run by Seattle Children's Hospital at 1 site in United States.
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 5 Jan 2012. 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 United States. 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?
Community walking activity with the STEPWATCH accelerometer (time frame: Assessed at one time point with a 7-10 walking sample). 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 5 Jan 2012.