Trial Outcomes & Findings for Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations (NCT NCT03756571)

NCT ID: NCT03756571

Last Updated: 2021-10-14

Results Overview

The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 months post wearing assigned orthotic intervention
• Results posted on: 2021-10-14

Participant Flow

All participants were approached and recruited through clinical care at Seattle Children's Hospital (SCH) or regionally by study team, once clinically deemed to meet inclusion criteria.

This was a randomized cross over design where those who randomized to TSAFO group first then crossed over without a washout period to the AFOFC treatment arm after 3 months of wearing the TSAFO.

Participant milestones

Measure	Ankle Foot Orthoses-Footwear Combination The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Overall Study STARTED	10	11
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Ankle Foot Orthoses-Footwear Combination The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations

Baseline characteristics by cohort

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.	Total n=19 Participants Total of all reporting groups
Age, Continuous	7.3 years n=5 Participants	6.6 years n=7 Participants	6.9 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

The Gait Profile Score (GPS) represents the pattern of deviation as a single number and is derived from the same individual joint/limb gait kinematics as Gait Deviation Index (GDI) The GPS minimum value is 0 and maximum value is 20. A higher score is a worse outcome. An minimally clinically important difference is published to be 1.6 for children with CP.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=7 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=6 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Baseline Gait Profile Score (GPS) at 3 Months-individual Lower Extremity Joint Kinematics	0.41 units on a scale Standard Deviation 1.95	-0.48 units on a scale Standard Deviation 1.47

PRIMARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side left/right. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the normal range. A higher score is a better outcome.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=7 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=6 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Right Baseline Gait Deviation Index (GDI) at 3 Months	.07 units on a scale Standard Deviation 10.2	3.2 units on a scale Standard Deviation 5.8

PRIMARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Gait speed will be captured during the three dimensional gait analysis testing. Gait speed is measured in meters per second (m/sec) with range from 0 to ~ 3.0 m/sec for walking in children. A higher number of m/sec is considered a better outcome with minimally clinically important difference (MCID) of .10 m/s for persons with CP.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=7 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=6 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Baseline Walking Speed in Meters/Second (m/s) at 3 Months.	-.03 meters/second (m/s) Standard Deviation 18	.13 meters/second (m/s) Standard Deviation .16

PRIMARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Community walking activity will be captured by the ankle worn StepWatch ® accelerometer capturing change in average strides/day. The StepWatch ® is a two dimension accelerometer validated to capture when the foot leaves the ground for a metric of stride counts within the context of daily life. Average strides/day can range from 0 to unlimited strides/day. A higher number of strides/day is considered a better outcome.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Baseline Community Walking Activity Level at 3 Months in Strides/Day.	-804 strides/day Standard Deviation 1131	-182 strides/day Standard Deviation 813

PRIMARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Community walking activity will be captured by the ankle worn StepWatch Accelerometer capturing % time at high stride rates. Percent time at high stride rates (> 60 strides/min) can range from 0 to 100% with a higher percent considered a better outcome.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Baseline Community Walking Intensity at 3 Months in Percent Time in High Stride Rates of > 60 Strides/Minute.	-.03 percentage of time in > 60 strides/min Standard Deviation 0.24	-.15 percentage of time in > 60 strides/min Standard Deviation 0.86

PRIMARY outcome

Timeframe: Change in Right baseline Gait Deviation Index (GDI) at 3 months

Gait Deviation Index (GDI) as a value representing overall gait deviation from a normal kinematic profile (0 to 120 scale) captures cumulative changes occurring at multiple joints and segments by side LEFT/RIGHT. GDI has been shown to have concurrent validity with gross motor function and functional walking levels in children with CP. A score > 100 is considered in the 'normal' range. A higher score is a better outcome.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=7 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=6 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Left Baseline Gait Deviation Index (GDI) at 3 Months	-1.5 units on a scale Standard Deviation 2.7	1.3 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

The Pediatric Balance Scale (PBS) is a functional measure intended to assess balance in a clinical setting for children with neurological impairment. The PBS is a scaled scoring with range of 0 to 100 with a higher score a better outcome.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Balance From Baseline to 3 Months as Measured by Pediatric Balance Scale.	12.8 score on a scale Standard Deviation 10.5	3.5 score on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Gait Outcomes Assessment List (GOAL) - The Gait Outcomes Assessment List (GOAL) is a outcome assessment to evaluate gait priorities and functional mobility for ambulant children with CP. The GOAL range of standard scores is 0 to 100 with a high score a better outcome. The GOAL will allow clinicians to better understand the motor abilities, priorities, and expectations of ambulant children with CP and to improve decision-making about appropriate interventions. The GOAL consists of 48 items grouped into seven domains: 1) activities of daily living and independence; 2) gait function and mobility; 3) pain, discomfort and fatigue; 4) physical activities, sports and recreation; 5) gait pattern and appearance; 6) use of braces and mobility aids; and 7) body image and self-esteem.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Change in Mobility From Baseline to 3 Months Change in Gait Outcome Assessment List (GOAL) Total Standard Score .	7.91 score on a scale Standard Deviation 9.2	-0.44 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Parental report of Physical Function Mobility subscale T-scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric survey. The PROMIS Physical Function subscale T score range is 0 to 100 with a higher score a better outcome. The mean of the T-score for Physical Function Mobility is 50 with a SD of 10, For parental report a score > or equal to 45 is consider Good, 36 - 44 Fair and < or equal to 35 Poor physical Function

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Difference Between Groups in Physical Function T-scores of Patient-Reported Outcomes Measurement Information System (PROMIS) After 3 Months Wearing Devices/Shoes.	36.2 T score Standard Deviation 3.8	32.9 T score Standard Deviation 3.9

SECONDARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Parental report of pain/fatigue domain standard scores on the Gait Outcomes Assessment List (GOAL). The range of the pain/fatigue subscale of the GOAL 0 to 100. A higher score is a better outcome.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Difference Between Groups in Pain/Fatigue Level of the Gait Outcomes Assessment List (GOAL) After Wearing Devices/Shoes for 3 Months	88.3 score on a scale Standard Deviation 12.2	78.2 score on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Parental report of selected pain and pain interference items from the Patient-Reported Outcomes Measurement Information System (PROMIS)pediatric survey. The Pediatric PROMIS pain interference subscale T score range is 0 to 100 with a lower score a better outcome. The mean is 50 with SD of 10. For the Pain interference a T score < 50 is considered within normal limits.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Difference Between Groups in Pain Interference After Wearing Devices/Shoes for 3 Months Pain Interference T Scores From PROMIS Pediatric Survey	45.6 T score Standard Deviation 8.6	53.4 T score Standard Deviation 13.1

SECONDARY outcome

Timeframe: 3 months post wearing assigned orthotic intervention

Parental report of satisfaction raw score items from the Orthotic and Prosthetic Users' Survey (OPUS). The range of OPUS scores is 11-55 with a higher score a better outcome. The raw scores are employed as the survey validation for Rasch scores is not completed for children.

Outcome measures

Measure	Ankle Foot Orthoses-Footwear Combination n=9 Participants The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 Participants The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Difference Between Groups in Satisfaction With Orthoses/Shoes After Wearing for 3 Months Per Orthotic and Prosthetic Users Survey (OPUS).	42.1 score on a scale Standard Deviation 6.9	42.8 score on a scale Standard Deviation 4.7

Adverse Events

Ankle Foot Orthoses-Footwear Combination

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Traditional Solid Ankle AFO (TSAFO)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ankle Foot Orthoses-Footwear Combination n=9 participants at risk The intervention is a Ankle Foot Orthoses Footwear Combination (AFO-FC). This is some form of solid ankle AFO combined with modified footwear individually designed per algorithm. Ankle Foot Orthoses-Footwear Combination: This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.	Traditional Solid Ankle AFO (TSAFO) n=10 participants at risk The intervention is a solid AFO (SAFO) aligned with the ankle at 90 degrees and worn with regular footwear. We'll refer to this as the "traditional" SAFO (TSAFO)... Traditional Solid Ankle AFO (TSAFO): This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Congenital, familial and genetic disorders Mild	44.4% 4/9 • Number of events 7 • Adverse events were collected from baseline consent visit through 3 month follow-up of initial randomized phase of trial and through the second cross over phase to the AFOFC condition.	50.0% 5/10 • Number of events 5 • Adverse events were collected from baseline consent visit through 3 month follow-up of initial randomized phase of trial and through the second cross over phase to the AFOFC condition.
Congenital, familial and genetic disorders Moderate	22.2% 2/9 • Number of events 3 • Adverse events were collected from baseline consent visit through 3 month follow-up of initial randomized phase of trial and through the second cross over phase to the AFOFC condition.	60.0% 6/10 • Number of events 10 • Adverse events were collected from baseline consent visit through 3 month follow-up of initial randomized phase of trial and through the second cross over phase to the AFOFC condition.

Additional Information

Kristie Bjornson, PT, PhD

Seattle Children's Research Institute

Phone: 206-884-2066

Email: Kristie.bjornson@seattlechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place