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

NCT04759014 | Completed

• 1 other identifier: 11
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation

Keywords

Transtibial amputation; Prosthetic foot; Functional capacity; Satisfaction; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Likert scale

  through study completion, an average of one and a half months

Study Arms (2)

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

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

Interventions

The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life OTHER

The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Merve Orucu Atar, MD

  Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: February 13, 2021
• First Posted: February 17, 2021
• Study Start: February 18, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)