Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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
  Hide Participant Flow

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
No text entered.

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
  Hide Baseline Characteristics

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
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
  Show All 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


  More Information