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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:
ClinicalTrials.gov Identifier:
NCT00438750
First Posted: February 22, 2007
Last Update Posted: June 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
February 20, 2007
February 22, 2007
March 27, 2012
May 28, 2012
June 8, 2012
January 2007
May 2010   (Final data collection date for primary outcome measure)
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.

Range of Motion in Degrees of the Wrists
Complete list of historical versions of study NCT00438750 on ClinicalTrials.gov Archive Site
  • 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.
  • DASH score
  • Likert pain scale
  • pinch and grip strength
  • Gartland and Werely score
  • Mayo wrist score
Not Provided
Not Provided
 
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
The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Distal Radius Fractures
  • 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.
  • 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.
  • Experimental: Independent Home Exercises
    Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
    Intervention: Other: Independent Excercises
  • Experimental: Formal Therapy
    Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
    Intervention: Other: Occupational Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00438750
2006-P-001157
Not Provided
Not Provided
Not Provided
David C. Ring, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: David Ring, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP