Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 6:25 PM
Study NCT ID:
NCT00438750
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2007-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Occupational Therapy and Home Exercises for Adults With Operatively Treated Distal Radius Fractures
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Prospective Randomized Comparison of Occupational Therapy vs Home Exercises After Volar Plate Fixation of a Fracture of the Distal Radius
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: