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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
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
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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 ]

Measure Type Primary
Measure Title Range of Motion in Degrees of the Wrists
Measure Description

Mean arc of wrist flexion and extension six months after surgery.

Normal/expected range of motion for arc of wrist flexion and extension is approximately 160 degrees.
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
Range of Motion in Degrees of the Wrists  
[units: Degrees]
Mean ± Standard Deviation 		  129  ± 22.6     118  ± 17.7  

No statistical analysis provided for Range of Motion in Degrees of the Wrists



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

Measure Type Secondary
Measure Title Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Measure Description

The DASH questionnaire measures arm-specific perceived disability. It contains 30 items and is scaled between zero and 100 with higher scores indicating worse upper-extremity function.

Mean and standard deviations are identical for both arms.
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire  
[units: units on a scale]
Mean ± Standard Deviation 		  7.8  ± 7.8     6.7  ± 6.7  

No statistical analysis provided for Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire



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

Measure Type Secondary
Measure Title 10-point Ordinal Pain Scale
Measure Description A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
10-point Ordinal Pain Scale  
[units: units on a scale]
Mean ± Standard Deviation 		  0.8  ± 1.4     1.0  ± 1.8  

No statistical analysis provided for 10-point Ordinal Pain Scale



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

Measure Type Secondary
Measure Title Pinch Strength
Measure Description

Pinch strength measured with the B&L pinch gauge.

B&L Engineering is the official name of the company (nowhere is there an expansion of this acronym).
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
Pinch Strength  
[units: Pounds (lbs)]
Mean ± Standard Deviation 		  15  ± 4.3     17  ± 8.6  

No statistical analysis provided for Pinch Strength



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

Measure Type Secondary
Measure Title Gartland and Werley Score
Measure Description An objective evaluation of wrist function with 0 to 2 as excellent, 3-8 as good, 9-20 as fair, and 21 and above as poor range of motion.
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
Gartland and Werley Score  
[units: units on a scale]
Mean ± Standard Deviation 		  0.9  ± 1.2     1.1  ± 1.3  

No statistical analysis provided for Gartland and Werley Score



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

Measure Type Secondary
Measure Title Mayo Wrist Score
Measure Description A composite score based on pain intensity, range of motion, grip strength, and functional status. The scale is as follows: below 60 is poor, 60-80 is satisfactory, 80-90 is good, and 90-100 is excellent.
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
Mayo Wrist Score  
[units: units on a scale]
Mean ± Standard Deviation 		  83.4  ± 12.7     79.0  ± 9.9  

No statistical analysis provided for Mayo Wrist Score



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

Measure Type Secondary
Measure Title Grip Strength
Measure Description Measured with use of a grip meter as the average of three attempts.
Time Frame 6 months  
Safety Issue No  

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.

Measured Values
    Independent Exercise Cohort     Occupational Therapy Cohort  
Number of Participants Analyzed  
[units: participants]
 		  39     37  
Grip Strength  
[units: Pounds (lbs)]
Mean ± Standard Deviation 		  57  ± 18.5     51  ± 17.9  

No statistical analysis provided for Grip Strength




  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
No text entered.  


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