NCT01527162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 4, 2016

Completed
Last Updated

June 16, 2021

Status Verified

May 1, 2021

Enrollment Period

2.5 years

First QC Date

January 30, 2012

Results QC Date

November 16, 2015

Last Update Submit

May 25, 2021

Conditions

Cerebral Palsy

Keywords

Cerebral palsyorthoticssolid ankle foot orthoses

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Physical Activity Scale for Kids - Performance Version (ASKp)

    previous 7 day reference

  • Assessment of Life Habits for Children (LIFE-H)

    previous 7 day reference

Study Arms (2)

SAFO worn

EXPERIMENTAL

Child wears their prescribed SAFO for 14 days

Device: SAFO wornOther: SAFO not worn

SAFO not worn

NO INTERVENTION

Child does not wear the prescribed SAFO for 14 days

Interventions

SAFO wornDEVICE

Child wears their prescribed SAFO for 14 days by random assignment

Also known as: Solid ankle foot orthoses (SAFO)
SAFO worn
SAFO not wornOTHER

Child does not wear their prescirbed SAFO for 14 days by random assignment

Also known as: Solid ankle foot orthoses (SAFO)
SAFO worn

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2 to \<10 years
  • Gross Motor Function Classification Scale Score of 1 - 3 (ambulatory)
  • Diagnosed with bilateral cerebral palsy
  • Has dynamic equinus gait deformity, defined as PROM to neutral, with equinus weight bearing pattern.
  • Wears bilateral SAFO more than 8 hours per day for more than one month.
  • Has a SAFO prescription of ankle at neutral (zero plantarflexion, with \<10 degrees dorsiflexion).
  • The primary goal of the SAFO is to facilitate balance and walking
  • Has SAFOs fabricated by Cascade DAFO, Ferndale, WA.
  • Parent and child are willing to discontinue SAFO use for two weeks.

You may not qualify if:

  • Has visual impairment which limits physical activity.
  • Has had lower extremity Botox injections in the past 3 months.
  • Is expected to require changes to medications treating the movement disorder during the study period.
  • Has an uncontrolled seizure disorder which impacts mobility skills.
  • Has had neurosurgical or orthopedic surgeries in the past 6 months.
  • Has had other surgeries or procedures in the past two weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Childrens Research Institute

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Kristie Bjornson, PhD, PT
Organization
Seattle Children's Research Institute
kristie.bjornson@seattlechildrens.org
206 884-2066

Study Officials

  • Kristie Bjornson, PT, PhD, PCS

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 6, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 16, 2021

Results First Posted

February 4, 2016

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)