Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
|ClinicalTrials.gov Identifier: NCT00438750|
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : May 28, 2012
Last Update Posted : June 8, 2012
|Condition or disease||Intervention/treatment|
|Distal Radius Fractures||Other: Independent Excercises Other: Occupational Therapy|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius|
|Study Start Date :||January 2007|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Experimental: Independent Home Exercises
Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
Other: Independent Excercises
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.
Other: Occupational Therapy
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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- Grip Strength [ Time Frame: 6 months ]Measured with use of a grip meter as the average of three attempts.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438750
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||David Ring, MD, PhD||Massachusetts General Hospital|