NCT01684501

Brief Summary

The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.8 years

First QC Date

September 7, 2012

Last Update Submit

April 10, 2017

Conditions

Trans-tibial Amputation

Keywords

prosthesisamputeesgait

Outcome Measures

Primary Outcomes (1)

  • Ankle power generation

    Ankle power derived using a camera-based motion capture system during walking

    During the session trial (approx 10 minutes)

Secondary Outcomes (1)

  • Metabolic cost of ambulation

    During the session trial (approx 10 minutes)

Study Arms (1)

Amputees

Adults with history of traumatic unilateral transtibial amputation

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults with history of traumatic unilateral transtibial amputation

You may qualify if:

  • weigh more than 200 lbs
  • are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
  • have the ability to follow multi-step commands.

You may not qualify if:

  • score level D on the SIGAM mobility grade
  • have experienced 1 or more falls in the last month before the study
  • have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
  • the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
  • the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
  • Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Paolo Bonato

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Motion Analysis Laboratory

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 13, 2012

Study Start

May 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)