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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
transfemoral amputation
Adults with unilateral transfemoral amputation who indepently ambulates with a prosthetic limb.
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: 5 minutes
The Timed Up and Go test is a functional mobility test used to assess mobility and balance. The participant is instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the test is measured in seconds. The test is performed three times, and the mean of the three trials is recorded as the final score. Lower completion times indicate better functional mobility.
6 minute walk test
时间窗: 1 day
Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%)
时间窗: 1 day
Anthropometric measurements will be performed using a standard measuring tape. For the amputated limb, the distance will be measured from the greater trochanter to the distal end of the residual limb along the lateral midline. For the intact limb, the measurement will extend from the greater trochanter to the plantar surface of the foot. The difference between these two measurements will represent the length of the lost limb. The percentage of limb loss will then be calculated by comparing the lost length to the total length of the intact limb.
Isokinetic Strength Testing
时间窗: 5 days
Isokinetic muscle strength assessments will be conducted using the IsoMed 2000 Dynamometer (D\&R Ferstl GmbH, Hemau, Germany). Measurements will include peak torque (Nm) and total work (J) values for hip, knee, and ankle flexor/extensor muscles. Testing will be performed under the following angular velocities and repetitions: 1. Hip Flexion/Extension: 5 reps at 60°/s, 10 reps at 120°/s (supine position) 2. Knee Flexion/Extension: 5 reps at 60°/s, 10 reps at 180°/s (seated, hip at 90°) 3. Ankle Plantar/Dorsiflexion: 5 reps at 60°/s, 10 reps at 120°/s (seated, semi-flexed hip, 90° knee flexion) Rest periods will be given between measurements to minimize fatigue. Tests will be randomized across different joints and days to avoid order effects. Data will be summarized as peak torque and total work values for each muscle group at the specified angular velocities.
Stability Coefficient (Eyes Open and Closed), Single-Leg Stability of Intact Side, and Limits of Stability (mm)
时间窗: 1 day
Participants' balance abilities will be assessed using the Huber 360® Evolution (LPG Systems, Valence, France), a motorized multi-axial platform with integrated force sensors. The following parameters will be measured and reported: 1. Static balance with eyes open and eyes closed (coefficient of stability) 2. Single-Leg Stability on the intact limb (coefficient of stability) 3. Limits of stability quantified as sway in mm
次要结局
- The Amputee Mobility Predictor (AMP)(1 day)
- The Comprehensive Lower-limb Amputee Socket Survey (CLASS)(1 day)
研究者
Ceren Kuzu
PhD Candidate, Physiotherapist
Hacettepe University