Determining the Potential Benefit of Powered Prostheses

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-08-31

Brief Summary

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The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.

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Detailed Description

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Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.

Conditions

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Unilateral Traumatic Amputation Amputation, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Powered Ankle Prosthesis

In this condition, the participant is fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants will wear the device for 2 weeks.

Group Type EXPERIMENTAL

Powered ankle prosthesis

Intervention Type DEVICE

This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.

Dynamic Response Foot

In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long.

Group Type SHAM_COMPARATOR

Dynamic Response Foot

Intervention Type DEVICE

This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.

Interventions

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Powered ankle prosthesis

This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.

Intervention Type DEVICE

Dynamic Response Foot

This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes

Exclusion Criteria

* History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No