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Walking Characteristics of Patients With Amputation

Walking Characteristics of Patients With Amputation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05595291
Enrollment
100
Registered
2022-10-26
Start date
2023-02-05
Completion date
2023-02-15
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation

Keywords

amputation, walking, satisfaction, pain

Brief summary

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Detailed description

It is important to investigate the long-term changes in walking characteristics of patients with amputation and the factors affecting walking characteristics in these patients regarding prosthesis rehabilitation. The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Interventions

OTHERinvestigation of the factors affecting walking characteristics

In order to investigate the factors affecting walking characteristics, 2-minute walking test, 10-point VAS (overall prosthesis satisfaction level, socket comfort and satisfaction level, knee joint satisfaction level, prosthetic foot satisfaction level, pain level in amputated extremity) and locomotor capacity index will be applied.

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Aged between 18 and 65 * Presence of lower extremity amputation

Exclusion criteria

* Conditions that prevent the use of prosthesis (wound, pain, etc.) * Having a history of rheumatic disease * Having cardiac pathology * Having pulmonary pathology * Having a situation that prevents communication * Not giving written consent

Design outcomes

Primary

MeasureTime frameDescription
2-minute walking testthrough study completion, an average of one monthWalking distance will be evaluated using the two-minute walking test (2MWT). Patients will be instructed to walk quickly, safely, and as much distance as possible along a rectangular path.

Secondary

MeasureTime frameDescription
Visual Analog Scalethrough study completion, an average of one monthAll patients will mark the severity of amputated extremity pain on a Visual Analog Scale (VAS; from 0 (no pain) to 10 (worst pain)). The socket system comfort and satisfaction, knee joint satisfaction, prosthetic foot satisfaction and overall prosthesis satisfaction will be evaluated with a 10-point VAS (from 0 (absolutely dissatisfied) to 10 (absolutely satisfied)).
Locomotor capacity indexthrough study completion, an average of one monthThe Locomotor Capabilities Index (LCI) is a validated measure of lower-limb amputees' ability to perform activities with prosthesis. The total LCI score is the sum of the item scores and can range from 0 (worst) to 30 (best).

Contacts

Primary ContactYasin Demir, MD
yasin.demir3@saglik.gov.tr+903122911806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026