Transfemoral AmputationNCT06399471

Personalizing MPK Prescription

A study testing Microprocessor prosthetic knee in people with Transfemoral Amputation, run by Georgia Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Transfemoral Amputation
What is being tested?: Microprocessor prosthetic knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 25 Oct 2021to 2 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Georgia Institute of Technology
Atlanta, Georgia, 30332

Other trials in United States

About this study

Official title: Personalizing MPK Prescription for Individuals With Transfemoral Amputation

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
Being tested: Microprocessor prosthetic knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Microprocessor prosthetic kneeDevice
Also called C-Leg, Power Knee, Rheo
Microprocessor prosthetic knees for use in a transfemoral prosthesis

Study groups in NCT06399471
Study group	Role	What they receive
Study Microprocessor Prosthetic Knee	Experimental	Randomization to C-Leg 4.0, Rheo Knee and Power Knee Receives: Device: Microprocessor prosthetic knee

What is being measured

The primary outcome is the main question the study is designed to answer.

Ten Meter Walking Test
Self selected walking speed over ten meters of walking over ground.
Measured: 1 month
Two Minute Walking Test
Self selected walking speed over two minutes of walking over ground.
Measured: 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.
Measured: 1 month

Secondary outcomes (9)

Stance Time Asymmetry Index
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.
Measured: 1 month
Narrowing Beam Walking Test
A measure of balance via walking down a narrowing beam.
Measured: 1 month
Reported Falls
Average reported falls per day.
Measured: 1 month
Physiological Cost Index
A clinical measure of energy expenditure. This formula consists of working heart minus resting heart rate divided by speed.
Measured: 1 month
Stair Ascent Speed
Self selected walking speed during stair ascent.
Measured: 1 month
Stair Descent Speed
Self selected walking speed while descending stairs.
Measured: 1 month
Ramp Ascent Speed
Self selected walking speed while ascending a 5 degree incline.
Measured: 1 month
Ramp Descent Speed
Self selected walking speed while descending a 5 degree incline.
Measured: 1 month
Steps Per Day
Steps per day as measured by StepWatch.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 20212 Oct 2023

First posted3 May 2024
Study start25 Oct 2021
Primary completion2 Oct 2023
Study completion2 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Transfemoral AmputationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06399471
Sponsor's protocol ID: H21008
Other IDs: W81XWH-21-1-0686
Status last verified: Nov 2024
First submitted: 1 May 2024
Last updated: 14 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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. 2026 Mar;18(3):288-304. doi: 10.1002/pmrj.70028. Epub 2025 Oct 24.
PubMed 41133928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users

All Transfemoral Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalizing MPK Prescription for Individuals With Transfemoral Amputation
ClinicalTrials.gov ID: NCT06399471
Acronym / sponsor ID: H21008
Conditions: Transfemoral Amputation
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Georgia Institute of TechnologyUniversity, hospital or other
Study start: 25 Oct 2021 (actual)
Primary completion: 2 Oct 2023 (actual)
Study completion: 2 Oct 2023 (actual)
First posted: 3 May 2024 (actual)
Results: Posted 14 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Microprocessor Prosthetic Knee	Experimental	Device: Microprocessor prosthetic kneeRandomization to C-Leg 4.0, Rheo Knee and Power Knee

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Microprocessor prosthetic kneeAlso: C-Leg, Power Knee, RheoMicroprocessor prosthetic knees for use in a transfemoral prosthesis	Device	Study Microprocessor Prosthetic Knee

Primary outcome

Ten Meter Walking Test
Time frame: 1 month
Self selected walking speed over ten meters of walking over ground.
Two Minute Walking Test
Time frame: 1 month
Self selected walking speed over two minutes of walking over ground.
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.

9 secondary outcomes

Stance Time Asymmetry Index
Time frame: 1 month
Narrowing Beam Walking Test
Time frame: 1 month
Reported Falls
Time frame: 1 month
Physiological Cost Index
Time frame: 1 month
Stair Ascent Speed
Time frame: 1 month
Stair Descent Speed
Time frame: 1 month
Ramp Ascent Speed
Time frame: 1 month
Ramp Descent Speed
Time frame: 1 month
Steps Per Day
Time frame: 1 month

Results and safety

Results posted to the registry on 14 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prosthetic Knee Randomized	11	10

Primary outcome: Ten Meter Walking Test

Time frame: 1 month. Mean (Standard Deviation). Unit: Meters per second

Measure	Prosthetic Knee Randomized n = 10
Power Knee	0.9963 (0.2061)
C-Leg 4.0	1.1051 (0.2081)
Rheo	1.1111 (0.201)

Prosthetic Knee Randomized: p = 0.126, ANOVA
Prosthetic Knee Randomized: p = 0.015, ANOVA
Prosthetic Knee Randomized: p = 0.852, ANOVA

Population analysed: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.

Primary outcome: Two Minute Walking Test

Time frame: 1 month. Mean (Standard Deviation). Unit: Meters per second

Measure	Prosthetic Knee Randomized n = 10
Power Knee	1.073 (0.2415)
C-Leg 4.0	1.2106 (0.2025)
Rheo	1.1698 (0.2458)

Prosthetic Knee Randomized: p = 0.003, ANOVA
Prosthetic Knee Randomized: p = 0.027, ANOVA
Prosthetic Knee Randomized: p = 0.425, ANOVA

Population analysed: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.

Primary outcome: Prosthetic Evaluation Questionnaire (PEQ)

Time frame: 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Prosthetic Knee Randomized n = 10
Power Knee	69.4 (8.99)
C-Leg 4.0	83.2 (10.15)
Rheo	78.4 (11.75)

Prosthetic Knee Randomized: p = 0.006, Non-parametric Friedman's test with mult
Prosthetic Knee Randomized: p = 0.236, Non-parametric Friedman's test with mult
Prosthetic Knee Randomized: p = 0.118, Non-parametric Friedman's test with mult

Population analysed: 1 participant did not complete any of the conditions due to self withdrawal after consenting. Each participant wore all three knees during this trial.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ottobock C-Leg 4.0	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Ossur Rheo	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Ossur Power Knee	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41133928Herrin 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. 2026 Mar;18(3):288-304. doi: 10.1002/pmrj.70028. Epub 2025 Oct 24.
Individual participant dataSharing planned: No

Related trials for Transfemoral Amputation

Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Microprocessor prosthetic knee in people with Transfemoral Amputation, run by Georgia Institute of Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ten Meter Walking Test (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06399471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.