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Trial record 1 of 22 for:    cerebral palsy orthotics
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Orthotics in Ambulatory Cerebral Palsy (SAFO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristie Bjornson, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01527162
First received: January 30, 2012
Last updated: February 3, 2016
Last verified: February 2016
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cerebral Palsy
Interventions: Device: SAFO worn
Other: SAFO not worn

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Description
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 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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
  Description
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]
 11 
Age 
[Units: Participants]
 
<=18 years   11 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Full Range)
 4.3 
 (3.0 to 5.9) 
Gender 
[Units: Participants]
 
Female   4 
Male   7 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures
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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
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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
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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
e-mail: kristie.bjornson@seattlechildrens.org



Responsible Party: Kristie Bjornson, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01527162     History of Changes
Other Study ID Numbers: K23HD060764-03B
K23HD060764-03 ( US NIH Grant/Contract Award Number )
Study First Received: January 30, 2012
Results First Received: November 16, 2015
Last Updated: February 3, 2016
Health Authority: United States: Institutional Review Board