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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759014
• Other study ID #: 11
• Status: Completed
• Start date: February 18, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation

Intervention

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

Locations

Country	Name	City	State
Turkey	Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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