Back to resultsReducing Range of Motion Deficits Post Radial Fracture
Primary Purpose
Radius Fractures
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercises
Sponsored by
About this trial
This is an interventional prevention trial for Radius Fractures focused on measuring fracture, radius, adult, range of motion
Eligibility Criteria
Inclusion Criteria:
- patient experienced distal radial fracture
- patient is over 18 years of age
- patient can follow instructions and comply with protocol
- fracture is managed non-operatively
Exclusion Criteria:
- bilateral wrist fractures
- previous fracture to the affected wrist
- previous range of motion limitations to the affected wrist
- involvement of other upper extremity structures (i.e. shoulder)
Sites / Locations
- Pan Am Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Standard Care
Arm Description
This group will receive instructions on specific exercises to perform after randomization.
This group will receive standard care
Outcomes
Primary Outcome Measures
Change in range of motion
Secondary Outcome Measures
Complications
The number and type of complications will be collected and compared between groups
Full Information
NCT ID
NCT01262807
First Posted
December 15, 2010
Last Updated
June 5, 2015
Sponsor
University of Manitoba
Collaborators
Pan Am Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01262807
Brief Title
Reducing Range of Motion Deficits Post Radial Fracture
Official Title
Reducing Range of Motion Deficits With In-cast Exercises: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
Collaborators
Pan Am Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This a randomized controlled study to test the hypothesis that patients who perform in-cast exercises will have superior range of motion immediately post-cast removal, without a concomitant increase in complication rate when compared with a control group who receives standard post cast care which does not include the intervention exercises.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures
Keywords
fracture, radius, adult, range of motion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
This group will receive instructions on specific exercises to perform after randomization.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
This group will receive standard care
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
A specific set of standardized exercises will be taught to patients who are randomized to the intervention group. They will be instructed to do these exercises daily while in-cast. They will have an exercise log to track adherence.
Primary Outcome Measure Information:
Title
Change in range of motion
Time Frame
6 weeks, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Complications
Description
The number and type of complications will be collected and compared between groups
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient experienced distal radial fracture
patient is over 18 years of age
patient can follow instructions and comply with protocol
fracture is managed non-operatively
Exclusion Criteria:
bilateral wrist fractures
previous fracture to the affected wrist
previous range of motion limitations to the affected wrist
involvement of other upper extremity structures (i.e. shoulder)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Dubberley, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeff Leiter, PhD
Organizational Affiliation
Pan Am Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristy Wittmeier, PhD
Organizational Affiliation
Winnipeg Health Sciences Centre
Official's Role
Study Director
Facility Information:
Facility Name
Pan Am Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3E4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Reducing Range of Motion Deficits Post Radial Fracture
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