The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400127
Recruitment Status : Terminated (poor recruitment, pilot outcome measures inappropriate)
First Posted : November 16, 2006
Last Update Posted : June 4, 2009
Information provided by:
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Amputee Device: Silesian suspension belt Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees
Study Start Date : September 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Arm Intervention/treatment
Experimental: amputee Device: Silesian suspension belt

Primary Outcome Measures :
  1. Quiet standing balance
  2. Timed-up and Go
  3. ambulation profile
  4. questionnaire

Secondary Outcome Measures :
  1. demographics
  2. prosthetic components

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400127

Canada, Nova Scotia
Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, Canada, B3H 4K4
Sponsors and Collaborators
Nova Scotia Health Authority
Principal Investigator: James Adderson Capital Health, Canada

Responsible Party: James Adderson, Capital District Health Authority, Canada Identifier: NCT00400127     History of Changes
Other Study ID Numbers: CDHA015
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by Nova Scotia Health Authority:
transfemoral amputee
silicon suspension