Orthotics in Ambulatory Cerebral Palsy (SAFO)

• ClinicalTrials.gov Identifier: NCT01527162
• Recruitment Status: Completed
• First Posted: February 6, 2012
• Results First Posted: February 4, 2016
• Last Update Posted: June 16, 2021
• Sponsor: Seattle Children's Hospital
• Information provided by (Responsible Party): Kristie Bjornson, Seattle Children's Hospital

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	Not Applicable

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 (Clinical Trial)
• 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: January 2012
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 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 Name: Solid ankle foot orthoses (SAFO); Other: SAFO not worn; Child does not wear their prescirbed SAFO for 14 days by random assignment; Other Name: 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 [ 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.

Secondary Outcome Measures :

1. Physical Activity Scale for Kids - Performance Version (ASKp) [ Time Frame: 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) [ Time Frame: 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

• Ages Eligible for Study: 2 Years to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, Washington

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

More Information

• Responsible Party: Kristie Bjornson, Principal Investigator, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT01527162
• Other Study ID Numbers: K23HD060764-03B; K23HD060764-03 ( U.S. NIH Grant/Contract )
• First Posted: February 6, 2012
• Results First Posted: February 4, 2016
• Last Update Posted: June 16, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kristie Bjornson, Seattle Children's Hospital:

Cerebral palsy; orthotics; solid ankle foot orthoses

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases