NCT00400127

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

Enrollment Period

1.6 years

First QC Date

November 15, 2006

Last Update Submit

June 3, 2009

Conditions

Amputee

Keywords

transfemoral amputeesilicon suspensionbalancegait

Outcome Measures

Primary Outcomes (4)

  • Quiet standing balance

  • Timed-up and Go

  • ambulation profile

  • questionnaire

Secondary Outcomes (2)

  • demographics

  • prosthetic components

Study Arms (1)

amputee

EXPERIMENTAL
Device: Silesian suspension belt

Interventions

Silesian suspension beltDEVICE
amputee

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, B3H 4K4, Canada

Location

Study Officials

  • James Adderson

    Capital Health, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

September 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

June 4, 2009

Record last verified: 2009-06

Locations

CA(1)