Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
Primary Purpose
Distal Radius Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Independent Excercises
Occupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures focused on measuring distal radius fracture, rehabilitation, volar plate fixation, DASH questionnaire
Eligibility Criteria
Inclusion Criteria:
- Age 18 or greater.
- Isolated distal radial fracture.
- Fracture treated with volar plates, stable fixation.
- Initial treatment within 4 weeks of trauma.
Exclusion Criteria:
- Complex fractures that require additional or different material than volar plates.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Independent Home Exercises
Formal Therapy
Arm Description
Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Outcomes
Primary Outcome Measures
Range of Motion in Degrees of the Wrists
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.
Secondary Outcome Measures
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
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.
10-point Ordinal Pain Scale
A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.
Pinch Strength
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).
Gartland and Werley Score
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.
Mayo Wrist Score
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.
Grip Strength
Measured with use of a grip meter as the average of three attempts.
Full Information
NCT ID
NCT00438750
First Posted
February 20, 2007
Last Updated
June 1, 2012
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00438750
Brief Title
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
Official Title
Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.
Detailed Description
Operative treatment of distal radius fractures has become commonplace over the last three decades as our understanding of the relationship between the alignment of the distal radius and the function of the wrist and forearm has improved. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that it would be beneficial to allow early movement of the wrist articulation in an attempt to maximize final outcome. There is a difference in opinion among physicians on the importance of supervision of exercises in the recovery process. Some physicians advocate formal occupational therapy while other physicians believe that appropriate instructions for home exercises are just as good. A common belief is that the motivation of the patient plays an important part in recovery. In addition, Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery. The goal of this study is to determine which protocol for exercises leads to better outcome in patients treated for distal radius with a volar plate. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (motion, grip strength) and subjective (DASH questionnaire) measures of functional recovery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
distal radius fracture, rehabilitation, volar plate fixation, DASH questionnaire
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Independent Home Exercises
Arm Type
Experimental
Arm Description
Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
Arm Title
Formal Therapy
Arm Type
Experimental
Arm Description
Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Intervention Type
Other
Intervention Name(s)
Independent Excercises
Intervention Description
Subjects provided with wrist splint and instructions for independent exercises to perform at home on their own. Subjects were advised to perform exercises as often as possible, but at least three to four times a day for a minimum of thirty minutes. There was no formal strengthening program.
Intervention Type
Other
Intervention Name(s)
Occupational Therapy
Intervention Description
Subjects were prescribed formal occupational therapy with supervised exercises to regain digit, wrist, and forearm motion and to strengthen the hand. The content, frequency, and duration of the rehabilitation program were at the discretion of the treating hand therapist.
Primary Outcome Measure Information:
Title
Range of Motion in Degrees of the Wrists
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
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
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
Title
10-point Ordinal Pain Scale
Description
A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.
Time Frame
6 months
Title
Pinch Strength
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
Title
Gartland and Werley Score
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
Title
Mayo Wrist Score
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
Title
Grip Strength
Description
Measured with use of a grip meter as the average of three attempts.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or greater.
Isolated distal radial fracture.
Fracture treated with volar plates, stable fixation.
Initial treatment within 4 weeks of trauma.
Exclusion Criteria:
Complex fractures that require additional or different material than volar plates.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
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