NCT01262807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

December 15, 2010

Last Update Submit

June 5, 2015

Conditions

Radius Fractures

Keywords

fractureradiusadultrange of motion

Outcome Measures

Primary Outcomes (1)

  • Change in range of motion

    6 weeks, 6 months, 1 year

Secondary Outcomes (1)

  • Complications

    6 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

This group will receive instructions on specific exercises to perform after randomization.

Other: Exercises

Standard Care

NO INTERVENTION

This group will receive standard care

Interventions

ExercisesOTHER

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.

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

MeSH Terms

Conditions

Radius FracturesFractures, Bone

Interventions

Exercise

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamie Dubberley, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

  • Jeff Leiter, PhD

    Pan Am Clinic

    STUDY CHAIR

  • Kristy Wittmeier, PhD

    Winnipeg Health Sciences Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 17, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CA(1)