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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Amputation

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

Study type: Observational

Funder types: Other

Identifiers

NCT04759014

11

Details and patient eligibility

About

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.

Full 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).

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

Group 1

Description:

21 patients using non-articulated dynamic foot (non-articulating ankle, NAA)

Treatment:

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

Group 2

Description:

21 patients using dynamic foot with hydraulic ankle (articulating hydraulic ankle, AHA)

Treatment:

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