NCT00915109

Brief Summary

The purpose of this study is to evaluate whether there are quantifiable differences in walking stability, as measured by the acceleration of the trunk or the variation in step length, between people with unilateral below-knee amputations from vascular reasons or from trauma reasons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

3.2 years

First QC Date

June 3, 2009

Last Update Submit

September 18, 2012

Conditions

Keywords

amputeeslower limb

Study Arms (3)

vascular

People with a unilateral below-knee amputations due to a vascular reason

nonvascular

People with a below-knee amputation due to nonvascular reasons

Control

People with no gait impairments.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prosthetic outpatient clinic of one rehabilitation centre

You may qualify if:

  • be over the age of 18;
  • be able to walk comfortably for a minimum of two (2) minutes;
  • be willing to take part in the study, including signing the consent after carefully reading it;
  • be able to read and understand English and follow verbal and visual instructions;
  • are competent to give informed consent or have a proxy with power of attorney.
  • have an unilateral, transtibial amputation;
  • been fitted with a prosthesis for over six weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Scotia Rehabilitation Centre

Halifax, Nova Scotia, B3H 4K4, Canada

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Rehabilitation Engineer

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 5, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations