Reducing Range of Motion Deficits Post Radial Fracture

June 5, 2015 updated by: University of Manitoba

Reducing Range of Motion Deficits With In-cast Exercises: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3E4
        • Pan Am Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in range of motion
Time Frame: 6 weeks, 6 months, 1 year
6 weeks, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 6 weeks
The number and type of complications will be collected and compared between groups
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Pan Am 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (ESTIMATE)

December 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2010:187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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