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

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ClinicalTrials.gov Identifier: NCT00438750
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : May 28, 2012
Last Update Posted : June 8, 2012
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

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

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


  Outcome Measures

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

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