Arthropathy Due to Bleeding From HemophiliaNCT00972296
Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
An observational study of Arthropathy Due to Bleeding From Hemophilia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This project proposes to examine the difference in effectiveness of fracture boots and carbon fiber braces in the management of gait abnormalities and pain relief due to ankle pain from arthritis due to ankle bleeds. Fracture boots are "walking casts" that you can put on and take off. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Arthropathy Due to Bleeding From Hemophilia
- What is being tested?
- Carbon fiber ankle foot orthosis versus cast boot
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2017
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients followed at the Oregon Hemophilia Treatment Center
Who may be able to join
- Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Development and Rehabilitation Center, Oregon Health & Science University
Portland, Oregon, 97239
About this study
This project proposes to examine the difference in effectiveness of fracture boots and carbon fiber braces in the management of gait abnormalities and pain relief due to ankle pain from arthritis due to ankle bleeds. Fracture boots are "walking casts" that you can put on and take off. They prevent the ankle from moving and have a curved sole to mimic normal walking. They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and absorbing some of the body's own weight while walking. Carbon fiber braces use newer technology resulting in lighter and smaller braces. They are designed to assist with helping clear the toe and straighten the knee while walking.
Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by walking on a mat equipped with pressure sensors and will examine the effect of the fracture boot and the carbon fiber brace on how you walk. These tests will be compared to walking on the mat without either brace. The sensors on the mat will measure different aspects of gait such as step length and foot position. You will be asked questions about how much ankle pain you have using no brace compared to each brace.
Read more
People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They will be approached during routine clinic visits and will also be contacted by telephone.
Levels of pain will be measured before, during and after each trial using standardized visual analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will be used to determine effectiveness of each type of support.
Statisticians will be used to analyze results of the gait mat and pain scale measurements.
- Being tested
- Carbon fiber ankle foot orthosis versus cast boot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon fiber ankle foot orthosis versus cast bootDevice
Relief of ankle pain and normalizing of gait using either device.
| Study group | Role | What they receive |
|---|---|---|
| Persons with hemophilia with ankle pain | Not described Receives: Device: Carbon fiber ankle foot orthosis versus cast boot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief measured by lower pain score with either AFO or cast boot
Measured: Outcome to be assessed at the time of trial
Secondary outcomes (1)
Improvement of gait parameters
Measured: To be assessed at time of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthropathy Due to Bleeding From HemophiliaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Oleson, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972296
- Sponsor's protocol ID
- DOleson
- Status last verified
- Apr 2017
- First submitted
- 3 Sep 2009
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Bladen M, Alderson L, Khair K, Liesner R, Green J, Main E. Can early subclinical gait changes in children with haemophilia be identified using the GAITRite® walkway, Haemophilia; Sep2007, Vol. 13 Issue 5, p542-547 2. Wall J, Bruni B, Chapter 17, Clinical Gait Analysis: Temporal and Distance Parameters, Assessment in Occupational Therapy and Physical Therapy, edited by J.V. Van Deusen, 1996
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Ankle Braces in the Management of Ankle Pain in Hemophilia
- ClinicalTrials.gov ID
- NCT00972296
- Acronym / sponsor ID
- DOleson
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Sep 2009 (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 project proposes to examine the difference in effectiveness of fracture boots and carbon fiber braces in the management of gait abnormalities and pain relief due to ankle pain from arthritis due to ankle bleeds. Fracture boots are "walking casts" that you can put on and take off. They prevent the ankle from moving and have a curved sole to mimic normal walking. They can help relieve pain of ankle arthritis from ankle bleeds by stopping ankle motion and absorbing some of the body's own weight while walking. Carbon fiber braces use newer technology resulting in lighter and smaller braces. They are designed to assist with helping clear the toe and straighten the knee while walking.
Gait analysis wearing both the fracture boot and carbon fiber brace will be performed by walking on a mat equipped with pressure sensors and will examine the effect of the fracture boot and the carbon fiber brace on how you walk. These tests will be compared to walking on the mat without either brace. The sensors on the mat will measure different aspects of gait such as step length and foot position. You will be asked questions about how much ankle pain you have using no brace compared to each brace.
People with hemophilia A or B and ankle pain from bleeds will be asked to participate. They will be approached during routine clinic visits and will also be contacted by telephone.
Levels of pain will be measured before, during and after each trial using standardized visual analog and ordinal pain scales. Measurements from the gait mat and levels of pain relief will be used to determine effectiveness of each type of support.
Statisticians will be used to analyze results of the gait mat and pain scale measurements.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with hemophilia with ankle pain | – | Device: Carbon fiber ankle foot orthosis versus cast boot |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients followed at the Oregon Hemophilia Treatment Center
Key inclusion criteria (1 listed)
- Hemophilia A or B, with or without inhibitor, with unilateral or bilateral ankle pain
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Carbon fiber ankle foot orthosis versus cast bootRelief of ankle pain and normalizing of gait using either device. | Device | Persons with hemophilia with ankle pain |
Primary outcome
Pain relief measured by lower pain score with either AFO or cast boot
Time frame: Outcome to be assessed at the time of trial
1 secondary outcome
Improvement of gait parameters
Time frame: To be assessed at time of trial
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 4 Apr 2017.
- Background1. Bladen M, Alderson L, Khair K, Liesner R, Green J, Main E. Can early subclinical gait changes in children with haemophilia be identified using the GAITRite® walkway, Haemophilia; Sep2007, Vol. 13 Issue 5, p542-547 2. Wall J, Bruni B, Chapter 17, Clinical Gait Analysis: Temporal and Distance Parameters, Assessment in Occupational Therapy and Physical Therapy, edited by J.V. Van Deusen, 1996
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy Due to Bleeding From Hemophilia, run by Oregon Health and Science University at 1 site in United States.
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 1 inclusion and 1 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 4 Apr 2017. 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 United States. 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?
Pain relief measured by lower pain score with either AFO or cast boot (time frame: Outcome to be assessed at the time of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972296, which also lists 1 linked publication.
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 4 Apr 2017.