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Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ithaca College
ClinicalTrials.gov Identifier:
NCT00756457
First received: September 19, 2008
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: February 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Posterior Tibial Tendon Dysfunction
Interventions: Device: Bracing
Other: Strengthening exercises
Other: Stretching exercises

  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
From 2007 - 2009 88 potential participants were screened from a university medical center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Brace & Exercise Participants in Group A will undergo bracing and perform stretching exercises.
Brace Participants in Group B will undergo bracing and perform stretching and strengthening exercises.

Participant Flow:   Overall Study
    Brace & Exercise     Brace  
STARTED     20     19  
COMPLETED     19 [1]   17 [2]
NOT COMPLETED     1     2  
Lost to Follow-up                 1                 2  
[1] One participant in the Active treatment group decided to have surgery after the 2 week follow-up.
[2] One participant moved overseas; the other participant resumed cancer treatment



  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.
No text entered.

Reporting Groups
  Description
Brace & Exercise Participants in Group A will undergo bracing and perform stretching exercises.
Brace Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
Total Total of all reporting groups

Baseline Measures
    Brace & Exercise     Brace     Total  
Number of Participants  
[units: participants]
  20     19     39  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     14     27  
>=65 years     7     5     12  
Age  
[units: years]
Mean ± Standard Deviation
  57.4  ± 11.9     58.1  ± 9.3     57.7  ± 10.6  
Gender  
[units: participants]
     
Female     16     15     31  
Male     4     4     8  
Region of Enrollment  
[units: participants]
     
United States     20     19     39  



  Outcome Measures
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1.  Primary:   Foot Function Index(FFI)   [ Time Frame: Measured at Weeks 1, 6, and 12 ]

2.  Primary:   Short Musculoskeletal Functional Assessment   [ Time Frame: Measured at Weeks 1, 6, and 12 ]

3.  Secondary:   Foot Kinematics and Posterior Tibial Muscle Length (Estimated From Foot Kinematics)   [ Time Frame: Measured at Weeks 1,6 and 12 ]

4.  Secondary:   Foot Strength   [ Time Frame: Measured at Weeks 1, 6, and 12 ]


  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
No text entered.


  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: Jeff Houck, PhD
Organization: Ithaca College
phone: 585-340-9619
e-mail: jhouck@ithaca.edu


No publications provided


Responsible Party: Ithaca College
ClinicalTrials.gov Identifier: NCT00756457     History of Changes
Other Study ID Numbers: R15 AR054507, R15AR054507
Study First Received: September 19, 2008
Results First Received: February 14, 2013
Last Updated: June 30, 2014
Health Authority: United States: Federal Government