Radius FracturesNCT01262807
Reducing Range of Motion Deficits Post Radial Fracture
A study testing Exercises in people with Radius Fractures, run by University of Manitoba at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fractures
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Radius Fractures
- Being tested
- Exercises
- Keywords
- fracture, radius, adult, range of motion
- Medical subject headings
- Radius Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | This group will receive instructions on specific exercises to perform after randomization. Receives: Other: Exercises |
| Standard Care | No intervention | This group will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion
Measured: 6 weeks, 6 months, 1 year
Secondary outcomes (1)
Complications
The number and type of complications will be collected and compared between groups
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FracturesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Pan Am Clinic
- Investigators
- Jamie Dubberley, MD, Principal investigator, University of ManitobaJeff Leiter, PhD, Study chair, Pan Am ClinicKristy Wittmeier, PhD, Study director, Winnipeg Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262807
- Sponsor's protocol ID
- H2010:187
- Status last verified
- Jun 2015
- First submitted
- 15 Dec 2010
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Range of Motion Deficits With In-cast Exercises: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01262807
- Acronym / sponsor ID
- H2010:187
- Conditions
- Radius Fractures
- Keywords
- fracture, radius, adult, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Pan Am Clinic
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExercisesThis group will receive instructions on specific exercises to perform after randomization. |
| Standard Care | No intervention | –This group will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisesA 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. | Other | Exercise |
Primary outcome
Change in range of motion
Time frame: 6 weeks, 6 months, 1 year
1 secondary outcome
Complications
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Dubberley, MD principal investigator
University of Manitoba
Jeff Leiter, PhD study chair
Pan Am Clinic
Kristy Wittmeier, PhD study director
Winnipeg Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Radius Fractures, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in range of motion (time frame: 6 weeks, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.