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Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438750
First received: February 20, 2007
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
Results First Received: March 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Distal Radius Fractures
Interventions: Other: Independent Excercises
Other: Occupational Therapy

  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
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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
  Description
Independent Exercise Cohort Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
Occupational Therapy Cohort Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.

Participant Flow:   Overall Study
    Independent Exercise Cohort     Occupational Therapy Cohort  
STARTED     48     46  
COMPLETED     39     37  
NOT COMPLETED     9     9  



  Baseline Characteristics
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Reporting Groups
  Description
Independent Exercise Cohort Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
Occupational Therapy Cohort Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Total Total of all reporting groups

Baseline Measures
    Independent Exercise Cohort     Occupational Therapy Cohort     Total  
Number of Participants  
[units: participants]
 		  48     46     94  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     44     37     81  
>=65 years     4     9     13  
Age  
[units: years]
Mean ± Standard Deviation 		  49  ± 15     51  ± 15     50  ± 15  
Gender  
[units: participants]
 		     
Female     31     30     61  
Male     17     16     33  
Region of Enrollment  
[units: participants]
 		     
United States     48     46     94  



  Outcome Measures
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1.  Primary:   Range of Motion in Degrees of the Wrists   [ Time Frame: 6 months ]
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2.  Secondary:   Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire   [ Time Frame: 6 months ]
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3.  Secondary:   10-point Ordinal Pain Scale   [ Time Frame: 6 months ]
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4.  Secondary:   Pinch Strength   [ Time Frame: 6 months ]
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5.  Secondary:   Gartland and Werley Score   [ Time Frame: 6 months ]
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6.  Secondary:   Mayo Wrist Score   [ Time Frame: 6 months ]
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7.  Secondary:   Grip Strength   [ Time Frame: 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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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Results Point of Contact:  
Name/Title: David Ring, MD, PhD
Organization: Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital
phone: 617-724-3953
e-mail: dring@partners.org


No publications provided


Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438750     History of Changes
Other Study ID Numbers: 2006-P-001157
Study First Received: February 20, 2007
Results First Received: March 27, 2012
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board