The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation

The Effect of Using Two Different Prosthetic Feet on Functional Capacity, Pain Severity, Satisfaction Level and Quality of Life in High Activity Patients With Unilateral Transtibial Amputation

Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.

Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life

Detailed Description

Background: Prescribing optimal prosthetic feet to ensure successful rehabilitation is difficult since there are no generally established clinical guidelines based on objective data.

Aim: To investigate the effect of using non-articulated dynamic foot (non-articulating ankle, NAA) and dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA) on functional capacity, pain severity, satisfaction level and quality of life (QoL) in high activity patients with unilateral transtibial amputation.

Methods: Forty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Functional capacity will be evaluated using the six-minute walking test (6MWT). The severity of residual limb pain, sound limb pain and low back pain will be evaluated with a 10-point Visual Analogue Scale (VAS). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS. The QoL of each patient will be assessed using the Short Form 36 (SF-36).

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fourty-two patients with unilateral transtibial traumatic amputation will be participated in this cross-sectional study. Only participants using active vacuum-assisted suspension system will be included in the study in order to prevent any bias from suspansion system on the results.

Description

Inclusion Criteria:

• aged 18-65 years
• Medicare functional classification level K4 (very active)
• using the prosthesis for at least 6 months and at least 6 hrs a day
• using active vacuum-assisted suspension system

Exclusion Criteria:

• bilateral amputation,
• the presence of neurological, cardiovascular and pulmonary disease that could affect walking performance.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 21 patients using non-articulated dynamic foot (non-articulating ankle, NAA)	Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life; The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
Group 2; 21 patients using dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA)	Other: The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life; The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	All patients will mark the severity of residual limb pain, sound limb pain and low back pain on a Visual Analogue Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system, prosthetic foot and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)).	through study completion, an average of one and a half months
Short Form 36 (SF-36)	The QoL of each patient will be assessed using the Short Form 36 (SF-36). The validity and reliability of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales that include physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores illustrate better QoL.	through study completion, an average of one and a half months
The six-minute walking test (6MWT)	Functional capacity will be evaluated using the six-minute walking test (6MWT). The 6MWT evaluates walking function and endurance. Patients will be instructed to walk quickly, safely, and as much distance as possible along a rectangular path. The 6MWT is both valid and reliable among individuals with lower-limb loss.	through study completion, an average of one and a half months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert scale	Level of difficulty experienced during walking on straight road, walking uneven road, ascending stairs, descending stairs, ascending ramps and descending ramps will be recorded on a 5-point Likert scale ((1) very easy, (2) easy , (3) neutral, (4) difficult, (5) very difficult).	through study completion, an average of one and a half months

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Merve Orucu Atar, MD, Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2021
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (ACTUAL): February 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Satisfaction; Functional capacity; Prosthetic foot; Transtibial amputation
• Other Study ID Numbers: 11

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