The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
This study has been terminated.
(poor recruitment, pilot outcome measures inappropriate)
Sponsor:
Capital District Health Authority, Canada
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00400127
First received: November 15, 2006
Last updated: June 3, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Amputee |
Device: Silesian suspension belt |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees |
Resource links provided by NLM:
Further study details as provided by Capital District Health Authority, Canada:
Primary Outcome Measures:
- Quiet standing balance
- Timed-up and Go
- ambulation profile
- questionnaire
Secondary Outcome Measures:
- demographics
- prosthetic components
| Enrollment: | 6 |
| Study Start Date: | September 2005 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: amputee | Device: Silesian suspension belt |
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400127
Locations
| Canada, Nova Scotia | |
| Nova Scotia Rehabilitation Centre | |
| Halifax, Nova Scotia, Canada, B3H 4K4 | |
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
| Principal Investigator: | James Adderson | Capital Health, Canada |
More Information
No publications provided
| Responsible Party: | James Adderson, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT00400127 History of Changes |
| Other Study ID Numbers: | CDHA015 |
| Study First Received: | November 15, 2006 |
| Last Updated: | June 3, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Capital District Health Authority, Canada:
|
transfemoral amputee silicon suspension balance gait |
ClinicalTrials.gov processed this record on May 22, 2013