The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

This study has been terminated.
(poor recruitment, pilot outcome measures inappropriate)
Sponsor:
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
  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 April 17, 2014