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

Primary Purpose

Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Revo-M
Taleo
Proflex XC
Sponsored by
Otto Bock Healthcare Products GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Amputation Below Knee (Injury) focused on measuring Prosthetic foot, lower limb amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Artificial Limb Specialists
  • Dankmeyer Prosthetics & Orthotics
  • Optimus Prosthetics
  • Ability P&O

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Revo-M to Proflex XC

Proflex XC to Revo-M

Revo-M to Taleo

Taleo to Revo-M

Arm Description

Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC

Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M

Transfemoral amputees randomized to start with Revo-M and cross over to Taleo

Transfemoral amputees randomized to start with Taleo and cross over to Revo-M

Outcomes

Primary Outcome Measures

Change in patient-perceived mobility (PLUS-M) compared to baseline
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.
Change in patient-perceived activity restrictions (TAPES-AR) compared to baseline
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

Proportion of subjects showing improvement in walking endurance or perceived exertion in the 6-minute Walk Test
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.
Change in patient perceived balance (ABC) compared to baseline
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.
Change in functional satisfaction with prosthesis (TAPES-FUN) compared to baseline
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.

Full Information

First Posted
January 17, 2020
Last Updated
April 1, 2022
Sponsor
Otto Bock Healthcare Products GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04239222
Brief Title
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
Official Title
Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otto Bock Healthcare Products GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
Keywords
Prosthetic foot, lower limb amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized cross-over controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Revo-M to Proflex XC
Arm Type
Experimental
Arm Description
Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC
Arm Title
Proflex XC to Revo-M
Arm Type
Experimental
Arm Description
Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M
Arm Title
Revo-M to Taleo
Arm Type
Experimental
Arm Description
Transfemoral amputees randomized to start with Revo-M and cross over to Taleo
Arm Title
Taleo to Revo-M
Arm Type
Experimental
Arm Description
Transfemoral amputees randomized to start with Taleo and cross over to Revo-M
Intervention Type
Device
Intervention Name(s)
Revo-M
Intervention Description
Investigational energy storage and return prosthetic foot with using novel elastic elements.
Intervention Type
Device
Intervention Name(s)
Taleo
Intervention Description
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
Intervention Type
Device
Intervention Name(s)
Proflex XC
Intervention Description
Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
Primary Outcome Measure Information:
Title
Change in patient-perceived mobility (PLUS-M) compared to baseline
Description
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.
Time Frame
2 months after fitting with Revo-M
Title
Change in patient-perceived activity restrictions (TAPES-AR) compared to baseline
Description
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.
Time Frame
2 months after fitting with Revo-M
Secondary Outcome Measure Information:
Title
Proportion of subjects showing improvement in walking endurance or perceived exertion in the 6-minute Walk Test
Description
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.
Time Frame
2 months after fitting with Revo-M
Title
Change in patient perceived balance (ABC) compared to baseline
Description
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.
Time Frame
2 months after fitting with Revo-M
Title
Change in functional satisfaction with prosthesis (TAPES-FUN) compared to baseline
Description
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.
Time Frame
2 months after fitting with Revo-M

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Artificial Limb Specialists
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Dankmeyer Prosthetics & Orthotics
City
Linthicum
State/Province
Maryland
ZIP/Postal Code
21090
Country
United States
Facility Name
Optimus Prosthetics
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Ability P&O
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.

Learn more about this trial

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

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