GaitNCT00915109
Gait Stability of People With Lower-limb Amputations
An observational study of Gait and Balance, run by Kim Parker at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee amputations from vascular reasons or from trauma reasons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Aug 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prosthetic outpatient clinic of one rehabilitation centre
Who may be able to join
- be over the age of 18;
- be able to walk comfortably for a minimum of two (2) minutes;
- be willing to take part in the study, including signing the consent after carefully reading it;
- be able to read and understand English and follow verbal and visual instructions;
- are competent to give informed consent or have a proxy with power of attorney.
- have an unilateral, transtibial amputation;
- been fitted with a prosthesis for over six weeks.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee amputations from vascular reasons or from trauma reasons.
- Keywords
- amputees, lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vascular | People with a unilateral below-knee amputations due to a vascular reason | |
| nonvascular | People with a below-knee amputation due to nonvascular reasons | |
| Control | People with no gait impairments. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Parker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kim Parker, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915109
- Sponsor's protocol ID
- CDHA-RS-2010-026
- Status last verified
- Sep 2012
- First submitted
- 3 Jun 2009
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Stability of People With Lower-limb Amputations
- ClinicalTrials.gov ID
- NCT00915109
- Acronym / sponsor ID
- CDHA-RS-2010-026
- Keywords
- amputees, lower limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kim ParkerUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Jun 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.
The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee amputations from vascular reasons or from trauma reasons.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vascular | – | –People with a unilateral below-knee amputations due to a vascular reason |
| nonvascular | – | –People with a below-knee amputation due to nonvascular reasons |
| Control | – | –People with no gait impairments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prosthetic outpatient clinic of one rehabilitation centre
Key inclusion criteria (7 listed)
- be over the age of 18;
- be able to walk comfortably for a minimum of two (2) minutes;
- be willing to take part in the study, including signing the consent after carefully reading it;
- be able to read and understand English and follow verbal and visual instructions;
- are competent to give informed consent or have a proxy with power of attorney.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Sep 2012.
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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.
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 Gait and Balance, run by Kim Parker 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 7 inclusion and 0 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 19 Sep 2012. 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.
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 19 Sep 2012.