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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239222
Recruitment Status : Suspended (Study suspended due to COVID 19)
First Posted : January 27, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Otto Bock Healthcare Products GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Knee Device: Revo-M Device: Taleo Device: Proflex XC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized cross-over controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Revo-M to Proflex XC
Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC
Device: Revo-M
Investigational energy storage and return prosthetic foot with using novel elastic elements.

Device: Proflex XC
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
Device: Revo-M
Investigational energy storage and return prosthetic foot with using novel elastic elements.

Device: Proflex XC
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
Device: Revo-M
Investigational energy storage and return prosthetic foot with using novel elastic elements.

Device: Taleo
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
Device: Revo-M
Investigational energy storage and return prosthetic foot with using novel elastic elements.

Device: Taleo
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects




Primary Outcome Measures :
  1. 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. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Person is 18 years or older.
  2. Currently uses an energy storage and return foot.
  3. Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
  4. For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
  5. Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
  6. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
  7. Prosthetic foot size is 24 to 27 centimeters.
  8. Socket Comfort Score of at least 7
  9. Ability to read and understand English
  10. A person is able and willing to give consent

Exclusion Criteria:

  1. Current prosthetic foot is too old or worn out as assessed by the CPO.
  2. TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
  3. Patient is pregnant or planning to become pregnant.
  4. Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
  5. 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.).
  6. Ulceration or skin breakdown of the residual limb.
  7. Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239222


Locations
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United States, Ohio
Optimus Prosthetics
Dayton, Ohio, United States, 45414
Sponsors and Collaborators
Otto Bock Healthcare Products GmbH
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Responsible Party: Otto Bock Healthcare Products GmbH
ClinicalTrials.gov Identifier: NCT04239222    
Other Study ID Numbers: OB111
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otto Bock Healthcare Products GmbH:
Prosthetic foot, lower limb amputation
Additional relevant MeSH terms:
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Wounds and Injuries
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action