Personalizing MPK Prescription

NCT06399471 | Completed Results FDA Device

• 2 other identifiers: H21008W81XWH-21-1-0686
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transfemoral Amputation

Outcome Measures

Primary Outcomes (3)

• Ten Meter Walking Test

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

  1 month

• Two Minute Walking Test

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

  1 month

• Prosthetic Evaluation Questionnaire (PEQ)

  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.

  1 month

Secondary Outcomes (9)

• Stance Time Asymmetry Index

  1 month

• Narrowing Beam Walking Test

  1 month

• Reported Falls

  1 month

• Physiological Cost Index

  1 month

• Stair Ascent Speed

  1 month

Study Arms (1)

Study Microprocessor Prosthetic Knee

EXPERIMENTAL

Randomization to C-Leg 4.0, Rheo Knee and Power Knee

Device: Microprocessor prosthetic knee

Interventions

Microprocessor prosthetic knee DEVICE

Microprocessor prosthetic knees for use in a transfemoral prosthesis

Also known as: C-Leg, Power Knee, Rheo

Study Microprocessor Prosthetic Knee

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Institute of Technology: lead

Study Sites (1)

Georgia Institute of Technology

Atlanta, Georgia, 30332, United States

Location

Related Publications (1)

• Herrin K, Kestur S, Zhou S, O'Sullivan G, Snow T, Childers WL, Young A. Toward personalizing prosthesis prescription: A take-home study of three microprocessor-controlled prosthetic knees: A randomized crossover study. PM R. 2025 Oct 24. doi: 10.1002/pmrj.70028. Online ahead of print.

  PMID: 41133928 DERIVED

Results Point of Contact

• Title: Kinsey Herrin, MSPO, C/LPO, FAAOP, Senior Research Scientist
• Organization: Georgia Institute of Technology

kinsey.herrin@gatech.edu

470-578-7600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: October 25, 2021
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)