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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD060764-03 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAFO worn | Experimental | Child wears their prescribed SAFO for 14 days |
|
| SAFO not worn | No Intervention | Child does not wear the prescribed SAFO for 14 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAFO worn | Device | Child wears their prescribed SAFO for 14 days by random assignment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking Activity Levels | Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day. | average of 5 days of second week of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristie Bjornson, PT, PhD, PCS | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Childrens Research Institute | Seattle | Washington | 98121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAFO Worn First, Then Not Worn | Child wears their prescribed SAFO for 14 days by random assignment and then not worn |
| FG001 | SAFO NOT Worn First, Then Worn | Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ages 3.0 to 5.8 years, mean age 4.3 years, spastic diplegia cerebral palsy, all wearing current AFO bilaterally to enhance walking activity
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Activity Levels | Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day. | Posted | Mean | Standard Deviation | average total strides/day | average of 5 days of second week of intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAFO Worn | SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristie Bjornson, PhD, PT | Seattle Children's Research Institute | 206 884-2066 | kristie.bjornson@seattlechildrens.org |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| SAFO not worn | Other | Child does not wear their prescirbed SAFO for 14 days by random assignment |
|
|
| 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. | previous 7 day reference |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | previous 7 day reference |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | previous 7 day reference |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | SAFO Not Worn | SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment | 0 | 11 | 0 | 11 |
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| = 0.20 |
| 2-Sided |
| Superiority or Other (legacy) |