Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transfemoral Amputation. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Primary outcome measures
- Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%) [Time frame: 1 day]
- Isokinetic Strength Testing [Time frame: 5 days]
- Stability Coefficient (Eyes Open and Closed), Single-Leg Stability of Intact Side, and Limits of Stability (mm) [Time frame: 1 day]
- 6 minute walk test [Time frame: 1 day]
Secondary outcome measures (2)
- The Amputee Mobility Predictor (AMP) [Time frame: 1 day]
- The Comprehensive Lower-limb Amputee Socket Survey (CLASS) [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07032233 · FTREK25/31