The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 15, 2006

Last Updated Date

January 30, 2009

Start Date ^†

September 2005

Current Primary Outcome Measures ^†

Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire

Original Primary Outcome Measures ^†

Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire

Change History

Complete list of historical versions of study NCT00400127 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

demographics
prosthetic components

Original Secondary Outcome Measures ^†

demographics
prosthetic components

Descriptive Information

Brief Title ^†

The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Official Title ^†

The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Brief 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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Condition ^†

Amputee

Intervention ^†

Device: Silesian suspension belt

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

April 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400127

Responsible Party

James Adderson, Capital District Health Authority, Canada

Secondary IDs ^††

Study Sponsor ^†

Capital District Health Authority, Canada

Collaborators ^††

Investigators ^†

Principal Investigator:

James Adderson

Capital Health, Canada

Information Provided By

Capital District Health Authority, Canada

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.