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OpenTrials
Completed

NCT Number: NCT06399471

Personalizing MPK Prescription

In current clinical prosthetic practice, there is no evidence based method for selecting a microprocessor knee (MPK) joint for a patient with an above the knee amputation. Of individuals with amputation in veteran and service member populations, approximately 35% present with an above the knee amputation. It is well understood in clinical practice that MPKs provide numerous benefits to patients with amputations above the knee including improved gait, safety, comfort, confidence, reduced falls, balance, patient satisfaction and reduced energy expenditure, greater ease in negotiating varying terrains, improvements in multi-tasking and cost effectiveness. Studies that have investigated commercially available MPKs tend to lump all of them together within a single group rather than teasing out individual differences between each knee. Therefore, clinicians are left to rely on their own intuition and past experiences with an MPK when selecting for a patient with an above the knee amputation rather than making their decision based on evidence collected from the specific patient. This may mean that some individuals with an above the knee amputation may not be receiving the best component for them which may delay or inhibit their rehabilitation potential following their amputation.

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Key information

Conditions

Transfemoral Amputation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Institute of Technology

Atlanta, Georgia, 30332, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A unilateral transfemoral amputation of the lower limb at least six months post fitting of definitive lower extremity prosthesis
  • Habitual use of a lower extremity prosthesis in daily living activities (based on assessment of a physiatrist and/or prosthetist and patient self-report)
  • Aged between 18 to 75 years
  • K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of a physiatrist and/or prosthetist)

Exclusion criteria

  • Individuals with any significant neuromuscular or musculoskeletal disorder or other comorbidity that would interfere with participation (based on assessment of the physiatrist and/or prosthetist and patient self-report)
  • Individuals who have open wounds on their residual limb
  • Individuals with known visual impairments that would prevent them from safely operating a prosthesis during over ground walking or ascending stairs (based on assessment of the physiatrist and/or prosthetist and patient self-report)
  • Individuals with known hearing impairments or who use hearing aids that would prevent them from responding to an auditory instruction (based on assessment of the physiatrist and/or prosthetist and patient self-report)
  • Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments

Treatment and study plan

Microprocessor prosthetic knee

Device

Microprocessor prosthetic knees for use in a transfemoral prosthesis

Other names: C-Leg, Power Knee, Rheo

Primary outcomes

  1. Ten Meter Walking Test

    Time frame: 1 month

    Self selected walking speed over ten meters of walking over ground.

  2. Two Minute Walking Test

    Time frame: 1 month

    Self selected walking speed over two minutes of walking over ground.

  3. Prosthetic Evaluation Questionnaire (PEQ)

    Time frame: 1 month

    A patient reported survey on perceptions of a prosthesis. Scores range zero to one hundred with zero being representing a negative patient reported outcome and one hundred representing a positive patient reported outcome.

Secondary outcomes

  1. Stance Time Asymmetry Index

    Time frame: 1 month

    Stance time asymmetry index measures the percent difference in stance time between the prosthetic and sound side limbs. A value equal to zero is indicative of perfect symmetry. Negative values of ST asymmetry index are indicative of increased time spent on the sound side and positive values are indicative of increased time on the prosthetic side.

  2. Narrowing Beam Walking Test

    Time frame: 1 month

    A measure of balance via walking down a narrowing beam.

  3. Reported Falls

    Time frame: 1 month

    Average reported falls per day.

  4. Physiological Cost Index

    Time frame: 1 month

    A clinical measure of energy expenditure. This formula consists of working heart minus resting heart rate divided by speed.

  5. Stair Ascent Speed

    Time frame: 1 month

    Self selected walking speed during stair ascent.

  6. Stair Descent Speed

    Time frame: 1 month

    Self selected walking speed while descending stairs.

  7. Ramp Ascent Speed

    Time frame: 1 month

    Self selected walking speed while ascending a 5 degree incline.

  8. Ramp Descent Speed

    Time frame: 1 month

    Self selected walking speed while descending a 5 degree incline.

  9. Steps Per Day

    Time frame: 1 month

    Steps per day as measured by StepWatch.

Sponsors and collaborators

Lead sponsor

Georgia Institute of Technology

Other

Registry information

Official study title

Personalizing MPK Prescription for Individuals With Transfemoral Amputation

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 3, 2024
Registry last updated
Nov 14, 2024

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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