Cerebral Palsy
Conditions
Keywords
Cerebral palsy, orthotics, solid ankle foot orthoses
Brief 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.
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.
Interventions
OTHERSAFO not worn
Child does not wear their prescirbed SAFO for 14 days by random assignment
DEVICESAFO worn
Child wears their prescribed SAFO for 14 days by random assignment
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
1. Age 2 to \<10 years 2. Gross Motor Function Classification Scale Score of 1 - 3 (ambulatory) 3. Diagnosed with bilateral cerebral palsy 4. Has dynamic equinus gait deformity, defined as PROM to neutral, with equinus weight bearing pattern. 5. Wears bilateral SAFO more than 8 hours per day for more than one month. 6. Has a SAFO prescription of ankle at neutral (zero plantarflexion, with \<10 degrees dorsiflexion). 7. The primary goal of the SAFO is to facilitate balance and walking 8. Has SAFOs fabricated by Cascade DAFO, Ferndale, WA. 9. Parent and child are willing to discontinue SAFO use for two weeks.
Exclusion criteria
1. Has visual impairment which limits physical activity. 2. Has had lower extremity Botox injections in the past 3 months. 3. Is expected to require changes to medications treating the movement disorder during the study period. 4. Has an uncontrolled seizure disorder which impacts mobility skills. 5. Has had neurosurgical or orthopedic surgeries in the past 6 months. 6. Has had other surgeries or procedures in the past two weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Activity Levels | average of 5 days of second week of intervention | Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Scale for Kids - Performance Version (ASKp) | previous 7 day reference | 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. |
| Assessment of Life Habits for Children (LIFE-H) | previous 7 day reference | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.3 years |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Walking Activity Levels
Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.
Time frame: average of 5 days of second week of intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAFO Worn | Walking Activity Levels | 4660 average total strides/day | Standard Deviation 1421 |
| SAFO Not Worn | Walking Activity Levels | 4897 average total strides/day | Standard Deviation 1438 |
p-value: <0.05Wilcoxon (Mann-Whitney)
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.
Time frame: previous 7 day reference
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAFO Worn | Assessment of Life Habits for Children (LIFE-H) | 5.71 units on a scale | Standard Deviation 2 |
| SAFO Not Worn | Assessment of Life Habits for Children (LIFE-H) | 5.11 units on a scale | Standard Deviation 2.2 |
Comparison: Paired Wilcoxon Sign Rank TEstp-value: >0.54Wilcoxon (Mann-Whitney)
p-value: =0.2Wilcoxon (Mann-Whitney)
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.
Time frame: previous 7 day reference
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAFO Worn | Physical Activity Scale for Kids - Performance Version (ASKp) | 51.08 units on a scale | Standard Deviation 11.64 |
| SAFO Not Worn | Physical Activity Scale for Kids - Performance Version (ASKp) | 49.45 units on a scale | Standard Deviation 14.2 |
p-value: =0.14Wilcoxon (Mann-Whitney)