The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Amputee Clinical Trial

Official title:

The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00400127
• Other study ID #: CDHA015
• Status: Terminated
• Phase: N/A
• First received: November 15, 2006
• Last updated: June 3, 2009
• Start date: September 2005
• Est. completion date: April 2007

Study information

• Verified date: June 2009
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputee

Intervention

Device:
• Silesian suspension belt

Locations

Country	Name	City	State
Canada	Nova Scotia Rehabilitation Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quiet standing balance
Primary	Timed-up and Go
Primary	ambulation profile
Primary	questionnaire
Secondary	demographics
Secondary	prosthetic components