The Effect of Silicone Suspension on Standing Balance for Transfemoral Amputees

Not Applicable

Terminated

• Conditions: Amputee
• Interventions: Device: Silesian suspension belt

• Registration Number: NCT00400127
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-16
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-03
• Last Update Posted: 2009-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
amputee	Silesian suspension belt	-

Primary Outcome Measures

Name	Time	Method
Quiet standing balance
Timed-up and Go
ambulation profile
questionnaire

Secondary Outcome Measures

Name	Time	Method
demographics
prosthetic components

Trial Locations

Locations (1)

Nova Scotia Rehabilitation Centre; 🇨🇦 Halifax, Nova Scotia, Canada