Cerebral PalsySAFONCT01527162
Orthotics in Ambulatory Cerebral Palsy
A study testing SAFO worn and SAFO not worn in people with Cerebral Palsy, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day walking activity and life participation of ambulatory children with cerebral palsy. The investigators propose that SAFO have not effect on levels of walking and life participation versus not wearing the SAFO. Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- SAFO worn and SAFO not worn
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age 2 to <10 years
- Gross Motor Function Classification Scale Score of 1 - 3 (ambulatory)
- Diagnosed with bilateral cerebral palsy
- Has dynamic equinus gait deformity, defined as PROM to neutral, with equinus weight bearing pattern.
- Wears bilateral SAFO more than 8 hours per day for more than one month.
- Has a SAFO prescription of ankle at neutral (zero plantarflexion, with <10 degrees dorsiflexion).
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- The primary goal of the SAFO is to facilitate balance and walking
- Has SAFOs fabricated by Cascade DAFO, Ferndale, WA.
- Parent and child are willing to discontinue SAFO use for two weeks.
Who cannot join
- Has visual impairment which limits physical activity.
- Has had lower extremity Botox injections in the past 3 months.
- Is expected to require changes to medications treating the movement disorder during the study period.
- Has an uncontrolled seizure disorder which impacts mobility skills.
- Has had neurosurgical or orthopedic surgeries in the past 6 months.
- Has had other surgeries or procedures in the past two weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Childrens Research Institute
Seattle, Washington, 98121
About this study
Official title: Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy
This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day walking activity and life participation of ambulatory children with cerebral palsy. The investigators propose that SAFO have not effect on levels of walking and life participation versus not wearing the SAFO.
Read the detailed description
This is a repeated measures trial with randomization of intervention in a cross over design which will quantify daily walking and physical activity levels for children with cerebral palsy (CP) with and without use of a solid ankle foot orthotic (SAFO). Current orthotic management guidelines are based primarily on evidence that SAFO use positively impacts body function and structure in clinic and lab based observations of activity and movement. Prior research has determined that wearing a SAFO improves different aspects of gait and mobility (stride and step length, single limb stance, velocity) for children with CP. However, these studies have been limited by small sample sizes, lack of comparison groups, inconsistency of orthotic fabrication, lack of clear and simple outcome measures and/or randomized control designs. No prior studies have evaluated the effect of SAFO use on activity performance outcomes.
The purpose of this study is to determine the effect of wearing or not wearing current SAFO on a child's walking ability, participation in common life activities, and gait. Children ages 2 - < 10 years who have bilateral cerebral palsy, dynamic equinus gait deformity, and wear bilateral SAFOs fabricated by Cascade DAFO will be approached for participation. Enrolled children are randomly assigned to either wear or not wear their SAFOs for a 14 day intervention period. After this period is over, children will then do the opposite for a second 14 day intervention period. Children attend three study visits; at enrollment, after the first intervention period is over, and after the second intervention period. At the first visit, parents and children (where applicable) complete questionnaires regarding their participation in common life activities in the prior 7 days, and complete a walking evaluation. Children wear a StepWatch accelerometer during each intervention period, which counts the number of steps the child takes and the time each step was taken. After the second intervention period is complete, the child's participation in the research study is complete. One home visit is conducted at the end of each intervention period, where the questionnaires are repeated, and the StepWatch is downloaded and/or re - calibrated per protocol.
- Conditions
- Cerebral Palsy
- Being tested
- SAFO worn, SAFO not worn
- Keywords
- Cerebral palsy, orthotics, solid ankle foot orthoses
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFO wornDevice
Also called Solid ankle foot orthoses (SAFO)
Child wears their prescribed SAFO for 14 days by random assignment
SAFO not wornOther
Also called Solid ankle foot orthoses (SAFO)
Child does not wear their prescirbed SAFO for 14 days by random assignment
| Study group | Role | What they receive |
|---|---|---|
| SAFO worn | Experimental | Child wears their prescribed SAFO for 14 days Receives: Device: SAFO worn; Other: SAFO not worn |
| SAFO not worn | No intervention | Child does not wear the prescribed SAFO for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Activity Levels
Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.
Measured: average of 5 days of second week of intervention
Secondary outcomes (2)
Physical Activity Scale for Kids - Performance Version (ASKp)
Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.
Measured: previous 7 day reference
Assessment of Life Habits for Children (LIFE-H)
Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.
Measured: previous 7 day reference
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristie Bjornson, Seattle Children's Hospital
- Investigators
- Kristie Bjornson, PT, PhD, PCS, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527162
- Sponsor's protocol ID
- K23HD060764-03B
- Other IDs
- K23HD060764-03
- Acronym
- SAFO
- Status last verified
- May 2021
- First submitted
- 30 Jan 2012
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01527162
- Acronym / sponsor ID
- SAFO / K23HD060764-03B
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, orthotics, solid ankle foot orthoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Posted 4 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day walking activity and life participation of ambulatory children with cerebral palsy. The investigators propose that SAFO have not effect on levels of walking and life participation versus not wearing the SAFO.
Detailed description
This is a repeated measures trial with randomization of intervention in a cross over design which will quantify daily walking and physical activity levels for children with cerebral palsy (CP) with and without use of a solid ankle foot orthotic (SAFO). Current orthotic management guidelines are based primarily on evidence that SAFO use positively impacts body function and structure in clinic and lab based observations of activity and movement. Prior research has determined that wearing a SAFO improves different aspects of gait and mobility (stride and step length, single limb stance, velocity) for children with CP. However, these studies have been limited by small sample sizes, lack of comparison groups, inconsistency of orthotic fabrication, lack of clear and simple outcome measures and/or randomized control designs. No prior studies have evaluated the effect of SAFO use on activity performance outcomes.
The purpose of this study is to determine the effect of wearing or not wearing current SAFO on a child's walking ability, participation in common life activities, and gait. Children ages 2 - < 10 years who have bilateral cerebral palsy, dynamic equinus gait deformity, and wear bilateral SAFOs fabricated by Cascade DAFO will be approached for participation. Enrolled children are randomly assigned to either wear or not wear their SAFOs for a 14 day intervention period. After this period is over, children will then do the opposite for a second 14 day intervention period. Children attend three study visits; at enrollment, after the first intervention period is over, and after the second intervention period. At the first visit, parents and children (where applicable) complete questionnaires regarding their participation in common life activities in the prior 7 days, and complete a walking evaluation. Children wear a StepWatch accelerometer during each intervention period, which counts the number of steps the child takes and the time each step was taken. After the second intervention period is complete, the child's participation in the research study is complete. One home visit is conducted at the end of each intervention period, where the questionnaires are repeated, and the StepWatch is downloaded and/or re - calibrated per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFO worn | Experimental | Device: SAFO worn, Other: SAFO not wornChild wears their prescribed SAFO for 14 days |
| SAFO not worn | No intervention | –Child does not wear the prescribed SAFO for 14 days |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Age 2 to <10 years
- Gross Motor Function Classification Scale Score of 1 - 3 (ambulatory)
- Diagnosed with bilateral cerebral palsy
- Has dynamic equinus gait deformity, defined as PROM to neutral, with equinus weight bearing pattern.
- Wears bilateral SAFO more than 8 hours per day for more than one month.
Key exclusion criteria (6 listed)
- Has visual impairment which limits physical activity.
- Has had lower extremity Botox injections in the past 3 months.
- Is expected to require changes to medications treating the movement disorder during the study period.
- Has an uncontrolled seizure disorder which impacts mobility skills.
- Has had neurosurgical or orthopedic surgeries in the past 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFO wornAlso: Solid ankle foot orthoses (SAFO)Child wears their prescribed SAFO for 14 days by random assignment | Device | SAFO worn |
| SAFO not wornAlso: Solid ankle foot orthoses (SAFO)Child does not wear their prescirbed SAFO for 14 days by random assignment | Other | SAFO worn |
Primary outcome
Walking Activity Levels
Time frame: average of 5 days of second week of intervention
Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.
2 secondary outcomes
Physical Activity Scale for Kids - Performance Version (ASKp)
Time frame: previous 7 day reference
Assessment of Life Habits for Children (LIFE-H)
Time frame: previous 7 day reference
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kristie Bjornson, PT, PhD, PCS principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFO worn and SAFO not worn in people with 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 9 inclusion and 6 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 16 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Walking Activity Levels (time frame: average of 5 days of second week of intervention). 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 16 Jun 2021.