Reducing Range of Motion Deficits Post Radial Fracture

Radius Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262807
• Other study ID #: H2010:187
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: June 5, 2015
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University of Manitoba Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

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.

Locations

Country	Name	City	State
Canada	Pan Am Clinic	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Pan Am Minor Injury Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in range of motion		6 weeks, 6 months, 1 year	No
Secondary	Complications	The number and type of complications will be collected and compared between groups	6 weeks	Yes