Lower Limb Amputation Below Knee (Injury)NCT04239222

Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

A study testing Revo-M, Taleo and Proflex XC in people with Lower Limb Amputation Below Knee (Injury) and Lower Limb Amputation Above Knee (Injury), run by Otto Bock Healthcare Products GmbH at 4 sites 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

A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
What is being tested?: Revo-M, Taleo and Proflex XC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 4 sitesUnited States
Study dates: 10 Mar 2020to 11 Mar 2022
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Person is 18 years or older.
Currently uses an energy storage and return foot.
Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).

Show all 10Show fewer

Prosthetic foot size is 24 to 27 centimeters.
Socket Comfort Score of at least 7
Ability to read and understand English
A person is able and willing to give consent

Who cannot join

Current prosthetic foot is too old or worn out as assessed by the CPO.
TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
Patient is pregnant or planning to become pregnant.
Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).
Ulceration or skin breakdown of the residual limb.
Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Optimus Prosthetics
Dayton, Ohio, 45414
Ability P&O
Exton, Pennsylvania, 19341
Dankmeyer Prosthetics & Orthotics
Linthicum, Maryland, 21090
Artificial Limb Specialists
Mesa, Arizona, 85202

Other trials in United States

About this study

Official title: Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot

A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.

Read the detailed description

The purpose of the Revo-M Study is to characterize differences in performance and patient reported outcomes between the Revo investigational prosthetic foot and a comparative prosthetic foot (Taleo or Proflex XC) when compared to the control foot which is the subject's currently used energy storage and return (ESR) prosthetic foot. The data obtained from this study may also serve to determine the long-term performance of Revo.

Conditions: Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
Being tested: Revo-M, Taleo, Proflex XC
Keywords: Prosthetic foot, lower limb amputation
Medical subject headings: Wounds and Injuries

What participants receive

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

Revo-MDevice
Investigational energy storage and return prosthetic foot with using novel elastic elements.
TaleoDevice
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
Proflex XCDevice
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Study groups in NCT04239222
Study group	Role	What they receive
Revo-M to Proflex XC	Experimental	Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC Receives: Device: Revo-M; Device: Proflex XC
Proflex XC to Revo-M	Experimental	Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M Receives: Device: Revo-M; Device: Proflex XC
Revo-M to Taleo	Experimental	Transfemoral amputees randomized to start with Revo-M and cross over to Taleo Receives: Device: Revo-M; Device: Taleo
Taleo to Revo-M	Experimental	Transfemoral amputees randomized to start with Taleo and cross over to Revo-M Receives: Device: Revo-M; Device: Taleo

What is being measured

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

Patient-perceived Mobility (PLUS-M)™
Perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility. The T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample. A T-score greater than 57 indicates that the mobility is above the 75th percentile.
Measured: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)
Activity restrictions as measured by the Revised Trinity Amputation and Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR). The TAPES-AR subscale has 10 items on a three-point scale and the average score ranges from 0 to 2. A higher score indicates greater activity restriction.
Measured: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Secondary outcomes (3)

Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test
The percentage of subjects showing an improvement compared to baseline walking endurance as measured by the distance walked in the six minute walk test OR a decrease in the rating of perceived exertion (RPE) as measured by Borg CR100 while wearing the Revo-M. A clinically-significant improvement in the 6MWT is defined as a change in distance of greater than 45 meters. A clinically-significant improvement in the RPE is defined as a change greater than 10 points. The Borg CR100 scale has a minimum of 0 and a maximum of 100. Greater scores indicate higher perceived exertion.
Measured: 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Patient Perceived Balance Confidence (ABC)
Perception of balance confidence as measured by the extended Activities-specific Balance Confidence (ABC) Scale. The questionnaire provides a score that ranges from 0 to 100%. Higher scores indicate greater balance confidence.
Measured: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Functional Satisfaction With Prosthesis (TAPES-FUN)
To characterize the level of functional satisfaction as measured by the TAPES Functional Satisfaction (TAPES-FUN) subscale while wearing a given prosthetic foot. There are 5 items scaled from 1 to 5. The subscale provides a total score that ranges from 5 to 25. Higher scores indicate greater functional satisfaction.
Measured: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Timeline

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

10 Mar 202011 Mar 2022

First posted27 Jan 2020
Study start10 Mar 2020
Primary completion11 Mar 2022
Study completion11 Mar 2022

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 (2)Papers the sponsor has linked to this study.
Other trials for Lower Limb Amputation Below Knee (Injury)Studies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized cross-over controlled trial
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04239222
Sponsor's protocol ID: OB111
Status last verified: Jun 2024
First submitted: 17 Jan 2020
Last updated: 23 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to share IPD.

Publications

Gallagher P, Franchignoni F, Giordano A, MacLachlan M. Trinity amputation and prosthesis experience scales: a psychometric assessment using classical test theory and rasch analysis. Am J Phys Med Rehabil. 2010 Jun;89(6):487-96. doi: 10.1097/PHM.0b013e3181dd8cf1.
PubMed 20489393
Hafner BJ, Morgan SJ, Askew RL, Salem R. Psychometric evaluation of self-report outcome measures for prosthetic applications. J Rehabil Res Dev. 2016;53(6):797-812. doi: 10.1682/JRRD.2015.12.0228.
PubMed 28273329

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

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot
ClinicalTrials.gov ID: NCT04239222
Acronym / sponsor ID: OB111
Conditions: Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
Keywords: Prosthetic foot, lower limb amputation
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
Study start: 10 Mar 2020 (actual)
Primary completion: 11 Mar 2022 (actual)
Study completion: 11 Mar 2022 (actual)
First posted: 27 Jan 2020 (actual)
Results: Posted 23 Sep 2024

Clinical summary

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

A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Randomized cross-over controlled trial

Arm	Type	Receives
Revo-M to Proflex XC	Experimental	Device: Revo-M, Device: Proflex XCTranstibial amputees randomized to start with Revo-M and cross over to Proflex XC
Proflex XC to Revo-M	Experimental	Device: Revo-M, Device: Proflex XCTranstibial amputees randomized to start with Proflex XC and cross over to Revo-M
Revo-M to Taleo	Experimental	Device: Revo-M, Device: TaleoTransfemoral amputees randomized to start with Revo-M and cross over to Taleo
Taleo to Revo-M	Experimental	Device: Revo-M, Device: TaleoTransfemoral amputees randomized to start with Taleo and cross over to Revo-M

Who may qualify

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

Key inclusion criteria (10 listed)

Person is 18 years or older.
Currently uses an energy storage and return foot.
Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm

Key exclusion criteria (7 listed)

Current prosthetic foot is too old or worn out as assessed by the CPO.
TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
Patient is pregnant or planning to become pregnant.
Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).

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
Revo-MInvestigational energy storage and return prosthetic foot with using novel elastic elements.	Device	Proflex XC to Revo-M, Revo-M to Proflex XC, Revo-M to Taleo, Taleo to Revo-M
TaleoCommercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects	Device	Revo-M to Taleo, Taleo to Revo-M
Proflex XCCommercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects	Device	Proflex XC to Revo-M, Revo-M to Proflex XC

Primary outcome

Patient-perceived Mobility (PLUS-M)™
Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility. The T-score has a mean of 50 and a standard deviation (SD) of 10. A PLUS-M T-score of 50 represents the mean mobility reported by the development sample. A T-score greater than 57 indicates that the mobility is above the 75th percentile.
Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)
Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Activity restrictions as measured by the Revised Trinity Amputation and Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR). The TAPES-AR subscale has 10 items on a three-point scale and the average score ranges from 0 to 2. A higher score indicates greater activity restriction.

3 secondary outcomes

Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test
Time frame: 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Patient Perceived Balance Confidence (ABC)
Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot
Functional Satisfaction With Prosthesis (TAPES-FUN)
Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Results and safety

Results posted to the registry on 23 Sep 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
Revo-M to Proflex XC	6	6
Proflex XC to Revo-M	8	8
Revo-M to Taleo	4	3
Taleo to Revo-M	8	7

Primary outcome: Patient-perceived Mobility (PLUS-M)™

Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot. Mean (Standard Deviation). Unit: units on a scale

Measure	Baseline n = 24	Reference n = 22	Revo n = 23	Final n = 23
Value	57.2 (6.6)	56.9 (7.4)	58.3 (7.2)	57.6 (7.1)

Baseline vs Revo: Mean Difference (Final Values): 1.02, p = 0.286, Wilcoxon Signed Rank Test

Population analysed: ITT analysis

Primary outcome: Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale)

Time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot. Mean (Standard Deviation). Unit: score on a scale

Measure	Baseline n = 24	Reference n = 22	Revo n = 23	Final n = 23
Value	0.653 (0.362)	0.686 (0.432)	0.569 (0.399)	0.674 (0.388)

Baseline vs Revo: Mean Difference (Final Values): -0.094, p = 0.031, Wilcoxon Signed Rank Test

Population analysed: ITT analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the four periods in the study. Each home-use period was between 6 to 10 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Everyday Foot	1 of 26 (3.8%)	3 of 26 (11.5%)	0 of 26
Reference Foot	1 of 22 (4.5%)	7 of 22 (31.8%)	0 of 22
Revo-M	2 of 23 (8.7%)	6 of 23 (26.1%)	0 of 23

Limitations and caveats (from the sponsor): A small overall sample. One subject could not tolerate the Taleo foot for any amount of time and so was not assessed on the Taleo.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20489393Gallagher P, Franchignoni F, Giordano A, MacLachlan M. Trinity amputation and prosthesis experience scales: a psychometric assessment using classical test theory and rasch analysis. Am J Phys Med Rehabil. 2010 Jun;89(6):487-96. doi: 10.1097/PHM.0b013e3181dd8cf1.
Background: PubMed 28273329Hafner BJ, Morgan SJ, Askew RL, Salem R. Psychometric evaluation of self-report outcome measures for prosthetic applications. J Rehabil Res Dev. 2016;53(6):797-812. doi: 10.1682/JRRD.2015.12.0228.
Individual participant dataSharing planned: No. There is no plan to share IPD.

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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.

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

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 7 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 23 Sep 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?

Patient-perceived Mobility (PLUS-M)™ (time frame: baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot). The study lists 2 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 NCT04239222, which also lists 2 linked publications.

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 23 Sep 2024.