AmputeeNCT00400127
The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
A study testing Silesian suspension belt in people with Amputee, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputee
- What is being tested?
- Silesian suspension belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Apr 2007
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be forty-five (45) or older;
- unilateral transfemoral amputee;
- current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site;
- can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.);
- are in the process of being fitted with a silicon suction liner and pin system;
- are competent to give informed consent or have a proxy with power of attorney;
- have the written permission of the attending physician to participate;
- be willing to take part in the study, including signing the consent after carefully reading it.
Who cannot join
- have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician;
- have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician;
- have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.
- Conditions
- Amputee
- Being tested
- Silesian suspension belt
- Keywords
- transfemoral amputee, silicon suspension, balance, gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silesian suspension beltDevice
| Study group | Role | What they receive |
|---|---|---|
| amputee | Experimental | Not described Receives: Device: Silesian suspension belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire
Secondary outcomes (2)
demographics
prosthetic components
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startSep 2005
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: poor recruitment, pilot outcome measures inappropriate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Investigators
- James Adderson, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400127
- Sponsor's protocol ID
- CDHA015
- Status last verified
- Jun 2009
- First submitted
- 15 Nov 2006
- Last updated
- 4 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT00400127
- Acronym / sponsor ID
- CDHA015
- Conditions
- Amputee
- Keywords
- transfemoral amputee, silicon suspension, balance, gait
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment, pilot outcome measures inappropriate
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Nov 2006 (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 objective of this study is to test the hypothesis that silicone suction suspension without additional belt support does not significantly diminish the postural sway or walking performance of persons with transfemoral amputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| amputee | Experimental | Device: Silesian suspension belt |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- be forty-five (45) or older;
- unilateral transfemoral amputee;
- current patients of the QEII Health Sciences Centre Amputee Service based at the Rehab Site;
- can walk comfortably with their prosthesis for a minimum of 5 minutes, regardless of whether they require ambulation aids (i.e. canes, walkers, etc.);
- are in the process of being fitted with a silicon suction liner and pin system;
Key exclusion criteria (3 listed)
- have an unstable medical condition (e.g. angina, seizures), as determined by the attending or house physician;
- have major medical or neurological conditions that affect balance (specifically Parkinson's disease, stroke or Multiple Sclerosis), as determined by the physician or house staff physician;
- have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as determined by the attending or house physician.
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 |
|---|---|---|
| Silesian suspension belt | Device | amputee |
Primary outcome
Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire
2 secondary outcomes
demographics
prosthetic components
Results and safety
The study was stopped early (reason given: poor recruitment, pilot outcome measures inappropriate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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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.
James Adderson principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silesian suspension belt in people with Amputee, run by Nova Scotia Health Authority 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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Jun 2009. 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 was stopped early (reason given: poor recruitment, pilot outcome measures inappropriate). Results are not available in the source record.
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?
Quiet standing balance. The study lists 4 primary outcomes in all. 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 4 Jun 2009.