- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438750
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Independent Home Exercises
Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
|
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.
|
Experimental: Formal Therapy
Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion in Degrees of the Wrists
Time Frame: 6 months
|
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. |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time Frame: 6 months
|
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. |
6 months
|
10-point Ordinal Pain Scale
Time Frame: 6 months
|
A ten point scale for pain at rest, with 0 as no pain and 10 as worst pain ever.
|
6 months
|
Pinch Strength
Time Frame: 6 months
|
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). |
6 months
|
Gartland and Werley Score
Time Frame: 6 months
|
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.
|
6 months
|
Mayo Wrist Score
Time Frame: 6 months
|
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.
|
6 months
|
Grip Strength
Time Frame: 6 months
|
Measured with use of a grip meter as the average of three attempts.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-P-001157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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