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

NCT04239222 | Completed Results

• 1 other identifier: OB111
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Prosthetic foot, lower limb amputation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

• Patient Perceived Balance Confidence (ABC)

  baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

• Functional Satisfaction With Prosthesis (TAPES-FUN)

  baseline, 2 months after fitting with reference foot, Revo-M, or crossover back to baseline foot

Study Arms (4)

Revo-M to Proflex XC

EXPERIMENTAL

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

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

Device: Revo-M; Device: Proflex XC

Revo-M to Taleo

EXPERIMENTAL

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

Device: Revo-M; Device: Taleo

Taleo to Revo-M

EXPERIMENTAL

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

Device: Revo-M; Device: Taleo

Interventions

Revo-M DEVICE

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Proflex XC to Revo-M; Revo-M to Proflex XC; Revo-M to Taleo; Taleo to Revo-M

Taleo DEVICE

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

Revo-M to Taleo; Taleo to Revo-M

Proflex XC DEVICE

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Proflex XC to Revo-M; Revo-M to Proflex XC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead

Study Sites (4)

Artificial Limb Specialists

Mesa, Arizona, 85202, United States

Location

Dankmeyer Prosthetics & Orthotics

Linthicum, Maryland, 21090, United States

Location

Optimus Prosthetics

Dayton, Ohio, 45414, United States

Location

Ability P&O

Exton, Pennsylvania, 19341, United States

Location

Related Publications (2)

• 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.

  PMID: 20489393 BACKGROUND

• 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.

  PMID: 28273329 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Ottobock SE & Co. KGaA

pawel.maciejasz@ottobock.com

+4955278483054

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized cross-over controlled trial

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 27, 2020
• Study Start: March 10, 2020
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)