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Completed

NCT Number: NCT02828982

Determining the Potential Benefit of Powered Prostheses

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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Key information

Conditions

Unilateral Traumatic Amputation Amputation, Traumatic Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Powered ankle prosthesis

Device

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

Dynamic Response Foot

Device

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

Primary outcomes

  1. Metabolic Cost of Walking

    Time frame: Testing took place after wearing the prostheses for two weeks

    Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.

  2. Total Steps Outside the Home Over a Two Week Period

    Time frame: 2 weeks

    Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device

  3. Quality of Life (QoL) on a Short-Form 36

    Time frame: Questionnaire completed 2 weeks after wearing each prosthesis

    Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

Secondary outcomes

  1. Prosthetic Evaluation Questionnaire (PEQ)

    Time frame: Questionnaire completed 2 weeks after wearing each prosthesis

    Participants completed a survey to evaluate their prosthetic satisfaction (Prosthetic Evaluation Questionnaire) after each condition. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line (0 mm) to the point at which the respondent's mark crosses the line (up to 100 mm). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response.

    Ambulation - Greater number = increased perceived ambulation Appearance - Greater number = better appearance Frustration - Greater number = less frustration Perceived Response - Greater number = increased perceived response Residual Limb Health - Greater number = better residual limb health Social burden - Greater number = less social burden Sounds - Greater number = less sound Utility - Greater

  2. Muscle Activity in the Lower Limb

    Time frame: Testing took place after the participant wore the prosthesis for 2 weeks

    Participants walk on a treadmill while muscle activity from various lower limb muscles are monitored using electromyography. We calculated the integrated EMG (iEMG) for each muscle collected as the total activity in that muscle as a percentage of the maximum signal.

  3. Time to Fatigue

    Time frame: Testing took place after wearing the prostheses for two weeks

    Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded.

Sponsors and collaborators

Lead sponsor

Deanna H Gates

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2016
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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