Gait Stability of People With Lower-limb Amputations | NCT00915109

Studies
Gait Stability of People With Lower-limb Amputations

NCT00915109

Sponsor

Kim Parker

Status

Completed

Last Update Posted

Sep 19, 2012Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Gait
Balance

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 3, 2009

First Submission Date that Met QC Criteria

Jun 4, 2009

First Posted Date

Jun 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2012

Last Update Posted Date

Sep 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Prosthetic outpatient clinic of one rehabilitation centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nova Scotia Rehabilitation Centre		Halifax	Nova Scotia	B3H 4K4	Canada