- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239222
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
April 1, 2022 updated by: Otto Bock Healthcare Products GmbH
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Mesa, Arizona, United States, 85202
- Artificial Limb Specialists
-
-
Maryland
-
Linthicum, Maryland, United States, 21090
- Dankmeyer Prosthetics & Orthotics
-
-
Ohio
-
Dayton, Ohio, United States, 45414
- Optimus Prosthetics
-
-
Pennsylvania
-
Exton, Pennsylvania, United States, 19341
- Ability P&O
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Revo-M to Proflex XC
Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC
|
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
|
Experimental: Proflex XC to Revo-M
Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M
|
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
|
Experimental: Revo-M to Taleo
Transfemoral amputees randomized to start with Revo-M and cross over to Taleo
|
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
|
Experimental: Taleo to Revo-M
Transfemoral amputees randomized to start with Taleo and cross over to Revo-M
|
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient-perceived mobility (PLUS-M) compared to baseline
Time Frame: 2 months after fitting with Revo-M
|
The change from baseline 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.
|
2 months after fitting with Revo-M
|
Change in patient-perceived activity restrictions (TAPES-AR) compared to baseline
Time Frame: 2 months after fitting with Revo-M
|
The change from baseline level of activity restrictions as measured by the Trinity Amputation and Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR).
The TAPES-AR questionnaire provides a score ranging from 0 to 2. A high score is indicative of activity restriction.
|
2 months after fitting with Revo-M
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects showing improvement in walking endurance or perceived exertion in the 6-minute Walk Test
Time Frame: 2 months after fitting with Revo-M
|
The proportion of subjects showing an improvement in 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.
|
2 months after fitting with Revo-M
|
Change in patient perceived balance (ABC) compared to baseline
Time Frame: 2 months after fitting with Revo-M
|
The change from baseline 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.
|
2 months after fitting with Revo-M
|
Change in functional satisfaction with prosthesis (TAPES-FUN) compared to baseline
Time Frame: 2 months after fitting with Revo-M
|
To characterize the level of functional satisfaction as measured by the TAPES Functional Satisfaction (TAPES-FUN) subscale while wearing the Revo-M compared to the everyday feet.
The subscale provides a score that ranges from 5 to 15.
Higher scores indicate greater functional satisfaction.
|
2 months after fitting with Revo-M
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2020
Primary Completion (Actual)
March 11, 2022
Study Completion (Actual)
March 11, 2022
Study Registration Dates
First Submitted
January 17, 2020
First Submitted That Met QC Criteria
January 22, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
April 4, 2022
Last Update Submitted That Met QC Criteria
April 1, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- OB111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to share IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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