Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT07032233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length
Sponsor:
Ceren Kuzu
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: