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Reducing Range of Motion Deficits Post Radial Fracture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pan Am Minor Injury Clinic
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01262807
First received: December 15, 2010
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention
Radius Fractures
 Other: Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Range of Motion Deficits With In-cast Exercises: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in range of motion [ Time Frame: 6 weeks, 6 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The number and type of complications will be collected and compared between groups


Estimated Enrollment: 70
Study Start Date: December 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262807

Contacts
Contact: Kristy Wittmeier, PhD 204-787-8531 kwittmeier@hsc.mb.ca
Contact: Jeff Leiter, PhD 204-927-2665 jleiter@panamclinic.ca

Locations
Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada, R3M 3E4
Principal Investigator: Jamie Dubberley, MD            
Sub-Investigator: Jeff Leiter, PhD            
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
  More Information

No publications provided

Responsible Party: Jamie Dubberley, University of Manitoba
ClinicalTrials.gov Identifier: NCT01262807     History of Changes
Other Study ID Numbers: H2010:187
Study First Received: December 15, 2010
Last Updated: December 16, 2010
Health Authority: Canada: University of Manitoba Research Ethics Board

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

ClinicalTrials.gov processed this record on May 21, 2013