Comparison Between Three Types of Prosthetic Feet (ProSto)

Comparison Between Three Types of Prosthetic Feet: a Randomized Double-blind Controlled Single-subject Multiple-rater Trial

One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic, Leg, Lower, Between Knee and Ankle
• Intervention / Treatment: Device: C-SACH; Device: B-DER; Device: A-DER

Detailed Description

The prosthetic feet will be: one SACH foot (by Otto Bock - foot C, advertised for activity category 1) and two DER feet (Dynamic Motion by Otto Bock - foot B, advertised for activity category 2-3; and Triton by Otto Bock - foot A, advertised for activity category 3-4).

All the prosthetic feet are of the same size and chosen for the patient's weight. They will be covered so that neither the patient nor professionals will be able to see which prosthetic foot is being used.

The study is blinded because the prosthetist designated for changing the prosthetic feet will be the only one who will know which prosthetic is being used. The orientational sample size calculation and the randomisation plan were prepared by a statistician.

The first trial will be performed using the patient's own prosthetic foot in order to establish a baseline. The patient will then have to to compare the prosthetic feet with his own existing prosthetic foot and rate the ability to walk on even terrain (100m), uneven terrain (grass, 100m), decline and incline (i.e., slope), and up and down the stairs (one floor) on a five-point Likert-type scale (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better). After each trial he will also perform the one-leg standing test (with three repetitions) and the 10-meter walking test. Before each trial, the patient will be given 15 minutes for adaptation to each new prosthetic foot without the presence of the assessors.

The three expert observers will be: a physical and rehabilitation medicine specialist physician, a certified prosthetist-orthotist, and a physiotherapist. Each has got over 20 years of experience in rehabilitation of patients after amputation and observation of their gait. They will be blind to the currently used prosthetic foot. They will follow the patient and assess his walking using the same rating scale in comparison with the initial trial as the patient.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• active prosthetic foot user who walks several kilometers per day
• amputation at the trans-tibial level >5 years ago

Exclusion Criteria:

• other medical problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: C-SACH; All the interventions will be administered to the patient in this single-subject trial, each 6 times	Device: C-SACH; Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
Active Comparator: B-DER; All the interventions will be administered to the patient in this single-subject trial, each 6 times	Device: B-DER; Dynamic Motion by Otto Bock, advertised for activity category 2-3
Active Comparator: A-DER; All the interventions will be administered to the patient in this single-subject trial, each 6 times	Device: A-DER; Triton by Otto Bock, advertised for activity category 3-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating	Likert-type, compared to the patient's existing prosthetic foot (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better)	Immediately after each trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time that the patient can stand on the prosthetic foot	Measured by the one-leg standing test (average of three repetitions)	Immediately after the rating, repeated 3 times
Walking velocity	Measured by the 10-meter walking test	Immediately after the one-leg standing test

Collaborators and Investigators

• Sponsor: University Rehabilitation Institute, Republic of Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): February 10, 2017
• Study Completion (Actual): May 3, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: walking speed; gait pattern; prosthetic feet; one leg standing
• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: URIS201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No