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The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
This study is currently recruiting participants.
Verified by Capital District Health Authority, Canada, May 2008
Sponsored by: Capital District Health Authority, Canada
Information provided by: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00400127
  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

MedlinePlus related topics: Amputees
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title: The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

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

Estimated Enrollment: 25
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
  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

Contacts
Contact: Kim Parker, MASc, PEng 902-473-2893

Locations
Canada, Nova Scotia
Nova Scotia Rehabilitation Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 4K4
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: James Adderson Capital Health, Canada
  More Information

Study ID Numbers: CDHA015
Study First Received: November 15, 2006
Last Updated: May 30, 2008
ClinicalTrials.gov Identifier: NCT00400127  
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
transfemoral amputee
silicon suspension
balance
gait

Study placed in the following topic categories:
Silicon

ClinicalTrials.gov processed this record on January 16, 2009