Community Walking Trials: Comparing Prosthetic Feet

NCT03703232 | Completed Results FDA Device

• 1 other identifier: STUDY00001109
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. To accomplish this, the study will use a combination of laboratory motion analysis, functional tests, and community mobility trials where participants complete questionnaires and interviews about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. Individuals with amputations that participate in the (optional) motion analysis sub-study at the University of Washington will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The participants will rate their experiences using socket comfort score and the socket pressure score. Control participants recruited at the University of Washington to provide information about performance for people without amputation will go through the consenting process, then will be asked to complete forward walking, Figure-of-8 Walk Test, Narrowing Beam Walking Test, side-step, and walking across river rock surface. These tests will be conducted at a single session.

Conditions

Lower Extremity Amputation

Keywords

prosthesis; prosthetic; foot; ankle; mobility; amputee

Outcome Measures

Primary Outcomes (4)

• Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Ambulation Sub-Scale

  Self-report questionnaire. PEQ Subscales: The PEQ is a 9-scale instrument that has good psychometric properties and has been validated. The PEQ subscales have a range from 0 (worst) to 100 (best). PEQ subscales of residual limb health, ambulation, utility, and sounds were selected for this study and comprise a total of 24 visual analogue scale questions. ICC estimates for these subscales for the first and second administration ranged from 0.79 to 0.9.

  Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.

• Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Comfort Scale

  The intent of the CLASS is to provide greater insight into the cause of socket dissatisfaction compared to the Socket Comfort Score. To accomplish this, the CLASS includes 4 subcategories; 1) stability, 2) suspension, 3) comfort, and 4) appearance. Each subcategory contains 3-4 items scored using a 5-point scale that relate to common tasks such as standing, sitting, walking, and ascending and descending stairs. Scale range: 0-60 Values: 0 = worst outcome; 60 = best outcome Subscales:0-16

  Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.

• Difference Between Investigational Foot and Usual Foot in the Figure-of-8 Walking Test: Time

  The F8W was developed to represent walking skills used in everyday life, involving straight and curved paths in both right and left directions. It has been validated in older adult populations with mobility disability. Subjects will begin the task standing between the 2 cones. The subject will walk a figure 8 course 3 times for each condition at their self-selected pace and stop when they return to the start position. The outcomes of the test are the time to complete the course.

  Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.

• Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Scale Measuring How Prosthesis Helps or Hinders When Walking on a Challenging Surface

  Difference between investigational foot and usual foot of the average daily values of the visual analog scale of participant's perception of gait on challenging surface. Scale range: 0-100 Values: 0 = worst outcome; 100 = best outcome

  Daily for 2-4 weeks

Secondary Outcomes (7)

• Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Residual Limb Health Subscale

  Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.

• Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Stability Subscale

  Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.

• Difference Between Investigational Foot and Usual Foot in the Narrowing Beam Walking Test: Distance Travelled

  Baseline (A1), after 2-week trial of investigational foot (B). Primary analysis uses B minus A1.

• Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Balance Confidence

  Average of daily measurements for 2-4 weeks using the investigational foot (B) and 2-4 weeks using the usual foot (A2). Outcome is B- A2.

• Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Utility Subscale

  Baseline (A1), after 2-week trial of investigational foot (B), after return to usual foot for 2 weeks (A2). Primary analysis uses B minus A2.

Study Arms (1)

Lower extremity amputees

OTHER

Community walking trial comparing usual prosthetic foot with investigational prosthetic foot.

Device: Investigational prosthetic foot

Interventions

Investigational prosthetic foot DEVICE

Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.

Lower extremity amputees

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral below knee amputation, use a prosthetic foot for at least 1 year
• Ability to walk 400 meters on level ground without using a walking aid and without an increase in pain
• Ability to read, write, and comprehend English

You may not qualify if:

• Residual skin breakdown
• Weight over 300 lbs

Sponsors & Collaborators

• University of Washington: lead
• WillowWood Global LLC: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Legro MW, Reiber GD, Smith DG, del Aguila M, Larsen J, Boone D. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil. 1998 Aug;79(8):931-8. doi: 10.1016/s0003-9993(98)90090-9.

  PMID: 9710165 BACKGROUND

Results Point of Contact

• Title: Murray Maitland PT, PhD, Associate Professor
• Organization: University of Washington

mmaitlan@uw.edu

425-286-5278

Study Officials

• Murray Maitland, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine, Rehabilitation Medicine

Model Details: The research design is an A-B-A design, where the A condition is the participant's usual prosthetic foot and the B condition is the investigational foot.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: October 11, 2018
• Study Start: March 15, 2016
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)