Reducing Range of Motion Deficits Post Radial Fracture

Sponsor

University of Manitoba (Other)

Overall Status

Completed

CT.gov ID

NCT01262807

Collaborator

Pan Am Clinic (Other)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Radius Fractures	Other: Exercises	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in range of motion [6 weeks, 6 months, 1 year]

Secondary Outcome Measures

Complications [6 weeks]
The number and type of complications will be collected and compared between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pan Am Clinic	Winnipeg	Manitoba	Canada	R3M 3E4

Sponsors and Collaborators

University of Manitoba
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01262807

Other Study ID Numbers:

H2010:187

First Posted:

Dec 17, 2010

Last Update Posted:

Jun 8, 2015

Last Verified:

Jun 1, 2015

Keywords provided by , ,

Additional relevant MeSH terms:

Fractures, Bone

Radius Fractures

Study Results

No Results Posted as of Jun 8, 2015