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
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
May 28, 2012
CompletedJune 8, 2012
June 1, 2012
3.3 years
February 20, 2007
March 27, 2012
June 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Range of Motion in Degrees of the Wrists
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 Outcomes (6)
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
6 months
10-point Ordinal Pain Scale
6 months
Pinch Strength
6 months
Gartland and Werley Score
6 months
Mayo Wrist Score
6 months
- +1 more secondary outcomes
Study Arms (2)
Independent Home Exercises
EXPERIMENTALSubjects who learn their therapy exercises from the surgeon and practice them independently at home.
Formal Therapy
EXPERIMENTALSubjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18 or greater.
- Isolated distal radial fracture.
- Fracture treated with volar plates, stable fixation.
- Initial treatment within 4 weeks of trauma.
You may not qualify if:
- Complex fractures that require additional or different material than volar plates.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Ring, MD, PhD
- Organization
- Orthopaedic Hand and Upper Extremity Service, Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
David Ring, MD, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; Director of Research, Hand Service
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 22, 2007
Study Start
January 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 8, 2012
Results First Posted
May 28, 2012
Record last verified: 2012-06