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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:
ClinicalTrials.gov Identifier:
NCT00438750
First Posted: February 22, 2007
Last Update Posted: June 8, 2012
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.
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
Results First Submitted: March 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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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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.
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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 
Overall Participants Analyzed 
[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 ]

2.  Secondary:   Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire   [ Time Frame: 6 months ]

3.  Secondary:   10-point Ordinal Pain Scale   [ Time Frame: 6 months ]

4.  Secondary:   Pinch Strength   [ Time Frame: 6 months ]

5.  Secondary:   Gartland and Werley Score   [ Time Frame: 6 months ]

6.  Secondary:   Mayo Wrist Score   [ Time Frame: 6 months ]

7.  Secondary:   Grip Strength   [ Time Frame: 6 months ]


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



Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438750     History of Changes
Other Study ID Numbers: 2006-P-001157
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: March 27, 2012
Results First Posted: May 28, 2012
Last Update Posted: June 8, 2012