SAFO: Orthotics in Ambulatory Cerebral Palsy

• Sponsor: Seattle Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01527162
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Device: SAFO worn; Other: SAFO not worn	N/A

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

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Relationship of Orthotics to Activity and Participation in Children With Cerebral Palsy
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAFO worn Child wears their prescribed SAFO for 14 days	Device: SAFO worn; Child wears their prescribed SAFO for 14 days by random assignment; Other Names: Solid ankle foot orthoses (SAFO) ; Other: SAFO not worn; Child does not wear their prescirbed SAFO for 14 days by random assignment; Other Names: Solid ankle foot orthoses (SAFO)
No Intervention: SAFO not worn Child does not wear the prescribed SAFO for 14 days

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seattle Childrens Research Institute	Seattle	Washington	United States	98121

Sponsors and Collaborators

• Seattle Children's Hospital

Investigators

• Principal Investigator: Kristie Bjornson, PT, PhD, PCS, Seattle Children's

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kristie Bjornson, Principal Investigator, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT01527162
• Other Study ID Numbers: K23HD060764-03B; K23HD060764-03
• First Posted: Feb 6, 2012
• Last Update Posted: Jun 16, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kristie Bjornson, Principal Investigator, Seattle Children's Hospital: Cerebral palsy; orthotics; solid ankle foot orthoses
• Additional relevant MeSH terms: Paralysis; Cerebral Palsy

Study Results

Participant Flow

Arm/Group Title	SAFO Worn First, Then Not Worn	SAFO NOT Worn First, Then Worn
Arm/Group Description	Child wears their prescribed SAFO for 14 days by random assignment and then not worn	Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
Period Title: Overall Study
STARTED	6	5
COMPLETED	6	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	11
Age (Count of Participants)
<=18 years	11 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	4.3
Sex: Female, Male (Count of Participants)
Female	4 36.4%
Male	7 63.6%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Walking Activity Levels
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAFO Worn	SAFO Not Worn
Arm/Group Description	Child wears their prescribed SAFO for 14 days SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment	Child does not wear the prescribed SAFO for 14 days
Measure Participants	11	11
Mean (Standard Deviation) [average total strides/day]	4660 (1421)	4897 (1438)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SAFO Worn, SAFO Not Worn
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Physical Activity Scale for Kids - Performance Version (ASKp)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAFO Worn	SAFO Not Worn
Arm/Group Description	Child wears their prescribed SAFO for 14 days	Child does not wear the prescribed SAFO for 14 days
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	51.08 (11.64)	49.45 (14.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SAFO Worn, SAFO Not Worn
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	= 0.14
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Assessment of Life Habits for Children (LIFE-H)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAFO Worn	SAFO Not Worn
Arm/Group Description	Child wears their prescribed SAFO for 14 days	Child does not wears their prescribed SAFO for 14 days
Measure Participants	11	11
Mean (Standard Deviation) [units on a scale]	5.71 (2.0)	5.11 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SAFO Worn, SAFO Not Worn
	Comments	Paired Wilcoxon Sign Rank TEst
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>.54
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SAFO Worn, SAFO Not Worn
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	= 0.20
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	SAFO Worn		SAFO Not Worn
Arm/Group Description	SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment		SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment
All Cause Mortality
	SAFO Worn		SAFO Not Worn
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SAFO Worn		SAFO Not Worn
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	SAFO Worn		SAFO Not Worn
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.