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Reducing Range of Motion Deficits Post Radial Fracture

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ClinicalTrials.gov Identifier: NCT01262807
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Pan Am Minor Injury Clinic
Information provided by:
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Radius Fractures Other: Exercises Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Range of Motion Deficits With In-cast Exercises: A Randomized Controlled Trial
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
This group will receive instructions on specific exercises to perform after randomization.
Other: Exercises
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.

No Intervention: Standard Care
This group will receive standard care



Primary Outcome Measures :
  1. Change in range of motion [ Time Frame: 6 weeks, 6 months, 1 year ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: 6 weeks ]
    The number and type of complications will be collected and compared between groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262807


Locations
Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Sponsors and Collaborators
University of Manitoba
Pan Am Minor Injury Clinic
Investigators
Principal Investigator: Jamie Dubberley, MD University of Manitoba
Study Chair: Jeff Leiter, PhD Pan Am Clinic
Study Director: Kristy Wittmeier, PhD Winnipeg Health Sciences Centre

Responsible Party: Jamie Dubberley, University of Manitoba
ClinicalTrials.gov Identifier: NCT01262807     History of Changes
Other Study ID Numbers: H2010:187
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by University of Manitoba:
fracture
radius
adult
range of motion

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries