Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length

Официальное название

Assessment of Lower Extremity Muscle Strength, Balance, and Functional Capacity in Individuals With Transfemoral Amputation and Investigation of the Relationship With the Length of the Lost Extremity

Обзор

The goal of this observational study is to learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations. The main questions it aims to answer are: How does the length of the lost part of the leg, compared to the intact leg, affect muscle strength, balance, and functional capacity? Is muscle strength at specific lower limb joints related to balance and performance ? Participants will: Have muscle strength measured at all intact lower limb joints using an isokinetic dynamometer Complete balance assessments using force platform technology that measures weight distribution and evaluates both static and dynamic balance Perform a six-minute walk test to evaluate endurance and functional capacity The study will help improve understanding of how limb length and joint-specific muscle strength impact mobility, supporting the development of better rehabilitation programs for amputees.

Подробное описание

This study is a cross-sectional observational study designed to assess lower extremity muscle strength, balance, and functional capacity in individuals with unilateral transfemoral amputation. The primary aim is to examine how the length of the lost part of the limb, in relation to the intact limb, correlates with these physical performance parameters. This study does not involve any intervention or follow-up over time. All data will be collected at one time point. Therefore, although the registry requires a study model selection, the study design does not align with standard cohort or case-control models. For this reason, the "Other" option was selected as the most appropriate observational study model.

Первичные конечные точки

• Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%) [Срок оценки: 1 day]
• Isokinetic Strength Testing [Срок оценки: 5 days]
• Stability Coefficient (Eyes Open and Closed), Single-Leg Stability of Intact Side, and Limits of Stability (mm) [Срок оценки: 1 day]
• 6 minute walk test [Срок оценки: 1 day]

Вторичные конечные точки (2)

• The Amputee Mobility Predictor (AMP) [Срок оценки: 1 day]
• The Comprehensive Lower-limb Amputee Socket Survey (CLASS) [Срок оценки: 1 day]

Критерии участия

Критерии включения

Individuals will be included in the study if they:

Are between 18 and 50 years of age

Are literate

Have unilateral transfemoral amputation

Have no cardiovascular, orthopedic, cognitive, or neurological conditions that could negatively affect balance, gait, or muscle strength

Are able to ambulate independently with a prosthesis

Have been walking for at least 6 months

Voluntarily agree to participate in the study

Критерии исключения

Participants will be excluded from the study if:

They develop complications such as pain (rated 3 or higher on the Visual Analog Scale) or stump irritation during the course of the study

Their residual limb length is less than 25 cm from the greater trochanter, which exceeds the limitations of the isokinetic dynamometer attachments used in the study

They voluntarily withdraw from the study - in such cases, their data will be removed from the records

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07032233 · FTREK25/31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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