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Completed

NCT Number: NCT00438750

Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures

The purpose of this study is to compare to ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Independent Excercises

Other

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.

Occupational Therapy

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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. Grip Strength

    Time frame: 6 months

    Measured with use of a grip meter as the average of three attempts.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2007
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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