Clinical trial NCT04759014: The Effect of Using Two Different Prosthetic Feet in Patients With Unilateral Transtibial Amputation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Keywords: Transtibial amputation
Prosthetic foot
Functional capacity
Satisfaction
Quality of life
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: through study completion, an average of one and a half months
measure: Short Form 36 (SF-36)
timeFrame: through study completion, an average of one and a half months
measure: The six-minute walking test (6MWT)
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
measure: Likert scale
timeFrame: through study completion, an average of one and a half months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation, Education and Research Hospital
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
name: Merve Orucu Atar, MD
role: PRINCIPAL_INVESTIGATOR
References: