Orthotics in Ambulatory Cerebral Palsy (SAFO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527162
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cerebral Palsy
Interventions: Device: SAFO worn
Other: SAFO not worn

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
SAFO Worn First, Then Not Worn Child wears their prescribed SAFO for 14 days by random assignment and then not worn
SAFO NOT Worn First, Then Worn Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn

Participant Flow:   Overall Study
    SAFO Worn First, Then Not Worn   SAFO NOT Worn First, Then Worn
STARTED   6   5 
COMPLETED   6   5 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ages 3.0 to 5.8 years, mean age 4.3 years, spastic diplegia cerebral palsy, all wearing current AFO bilaterally to enhance walking activity

Reporting Groups
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.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   11 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Years]
Mean (Full Range)
 (3.0 to 5.9) 
[Units: Participants]
Female   4 
Male   7 
Region of Enrollment 
[Units: Participants]
United States   11 

  Outcome Measures

1.  Primary:   Walking Activity Levels   [ Time Frame: average of 5 days of second week of intervention ]

2.  Secondary:   Physical Activity Scale for Kids - Performance Version (ASKp)   [ Time Frame: previous 7 day reference ]

3.  Secondary:   Assessment of Life Habits for Children (LIFE-H)   [ Time Frame: previous 7 day reference ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  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.

Results Point of Contact:  
Name/Title: Kristie Bjornson, PhD, PT
Organization: Seattle Children's Research Institute
phone: 206 884-2066

Responsible Party: Kristie Bjornson, Seattle Children's Hospital Identifier: NCT01527162     History of Changes
Other Study ID Numbers: K23HD060764-03B
K23HD060764-03 ( U.S. NIH Grant/Contract )
First Submitted: January 30, 2012
First Posted: February 6, 2012
Results First Submitted: November 16, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016