Completed

Comparing Active and Passive Ankle-foot Prostheses

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

From 18 to 64 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: May 2010
See protocol details

Summary

Principal SponsorSpaulding Rehabilitation Hospital
Last updated: April 12, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2010

Actual date on which the first participant was enrolled.

Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

NCT01684501
Principal SponsorSpaulding Rehabilitation Hospital
Last updated: April 12, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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
weigh more than 200 lbs
6 exclusion criteria prevent from participating
Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation
have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
have experienced 1 or more falls in the last month before the study
score level D on the SIGAM mobility grade
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Spaulding Rehabilitation Hospital Boston

Boston, United StatesOpen Spaulding Rehabilitation Hospital Boston in Google Maps
CompletedOne Study Center