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Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss

Primary Purpose

Traumatic Amputation of Lower Extremity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ischemic Preconditioning
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Traumatic Amputation of Lower Extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least 18 years old History of lower limb unilateral transfemoral amputation. At least two years post lower limb amputation Able to ambulate independently without the use of aids (i.e., walking cane). Able to walk at least 10 minutes continuously without stopping. Has a safe residuum with no open wounds on either the residual or intact limb. Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study. Exclusion Criteria: Younger than 18 years old. Inability to give informed consent. Neurological disorder that affects gait. Participants with significant metal (greater than one orthopaedic screw) in either the residual limb or the sound/intact limb Participants who begin taking medications or change dosage of medications that could affect gait, balance, and cardiovascular function during the course of the study. Currently pregnant (or intend to become pregnant while participating in study). History of any condition where fatiguing contractions or resisted leg contractions are contraindicated. Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg). History of uncontrolled hypertension. History of heart failure. Head injury within the previous 6 months. Seizure disorder. History of vascular disease. History of thrombosis. History of sickle cell trait. History of genetic disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Ischemic Preconditioning at High Pressure

    Ischemic Preconditioning at Low Pressure

    Arm Description

    In this arm, the participant will receive ischemic preconditioning (a blood pressure cuff on the intact limb) inflated to 225mmHg for 5 minutes followed by 5 minutes of reperfusion on a cycle for a total of 50 minutes. This will be completed every other day for 7 session (14 days).

    In this arm, the participant will receive ischemic preconditioning (a blood pressure cuff on the intact limb) inflated to 25mmHg for 5 minutes followed by 5 minutes of reperfusion on a cycle for a total of 50 minutes. This will be completed every other day for 7 session (14 days).

    Outcomes

    Primary Outcome Measures

    Strength
    Comparing leg strength before and after intervention
    Gait
    Comparing leg strength before and after intervention
    Metabolics
    Comparing leg strength before and after intervention
    Daily Steps/Activity
    Comparing leg strength before and after intervention
    Arterial Stiffness
    Comparing leg strength before and after intervention

    Secondary Outcome Measures

    Full Information

    First Posted
    June 16, 2023
    Last Updated
    June 26, 2023
    Sponsor
    University of Illinois at Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05929508
    Brief Title
    Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
    Official Title
    Improving Mobility and Function Following Transfemoral Amputation: A Novel Approach to Reverse Volumetric Muscle Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 10, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2027 (Anticipated)
    Study Completion Date
    December 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Illinois at Chicago

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the relationship between thigh strength and walking ability and assess if using a blood pressure cuff on the leg improves strength and walking performance.
    Detailed Description
    One in every 190 Americans is currently living with the loss of a limb. Following lower limb amputation (LLA), individuals have double the risk of knee and hip pain, a high prevalence of osteoarthritis in the intact limb with a prevalence ratio of 3.3 compared to those without amputation, and up to 90% experience severe back pain. The long-term consequences of LLA may be mitigated through regular use of prosthesis and physical activity, which would also increase the likelihood of returning to work and reintegration of Service Members (SMs) and younger Veterans. Clinicians and researchers often focus on the prosthetic fit to improve outcomes, however just providing a prosthetic, even the most advanced prosthetic, is not enough to restore function. Interventions targeting physical capabilities to complement device intervention may be key to improving outcomes in individuals with LLA. Along with increased orthopaedic risks, individuals with traumatic LLA also have an increased risk of cardiovascular events compared to the general population. SMs with traumatic unilateral transfemoral amputation have a 1.58 times greater risk of death from cardiovascular causes and their relative risk of aortic aneurysm is 5.1 times greater than Veterans without amputation. There is evidence to suggest that individuals with LLA have increased peripheral vascular resistance following amputation, leading to vasoconstriction and increased blood pressure. Reduced arterial function (i.e. increased arterial stiffness) is an important measure in those with LLA because it predicts mortality, heart failure, and cardiovascular events. In addition, improved arterial function improves perfusion to muscle and reduces fatigue during exertion. Therefore, strategies that reduce arterial stiffness and vascular resistance in individuals with LLA are important to improve mortality and quality of life for SMs and Veterans. Therefore, we propose implementing ischemic preconditioning (IC) as a novel intervention to strengthen and hypertrophy leg muscles and increase arterial function for improving outcomes after amputation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Amputation of Lower Extremity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ischemic Preconditioning at High Pressure
    Arm Type
    Active Comparator
    Arm Description
    In this arm, the participant will receive ischemic preconditioning (a blood pressure cuff on the intact limb) inflated to 225mmHg for 5 minutes followed by 5 minutes of reperfusion on a cycle for a total of 50 minutes. This will be completed every other day for 7 session (14 days).
    Arm Title
    Ischemic Preconditioning at Low Pressure
    Arm Type
    Sham Comparator
    Arm Description
    In this arm, the participant will receive ischemic preconditioning (a blood pressure cuff on the intact limb) inflated to 25mmHg for 5 minutes followed by 5 minutes of reperfusion on a cycle for a total of 50 minutes. This will be completed every other day for 7 session (14 days).
    Intervention Type
    Other
    Intervention Name(s)
    Ischemic Preconditioning
    Intervention Description
    A blood pressure cuff will be placed on the thigh of the intact/sound limb to restrict blood flow to the lower extremity for 5 minutes and then deflated for 5 minutes to allow for normal blood flow on a cycle for 50 minutes (5 times).
    Primary Outcome Measure Information:
    Title
    Strength
    Description
    Comparing leg strength before and after intervention
    Time Frame
    through study completion, an average of 6 weeks
    Title
    Gait
    Description
    Comparing leg strength before and after intervention
    Time Frame
    through study completion, an average of 6 weeks
    Title
    Metabolics
    Description
    Comparing leg strength before and after intervention
    Time Frame
    through study completion, an average of 6 weeks
    Title
    Daily Steps/Activity
    Description
    Comparing leg strength before and after intervention
    Time Frame
    through study completion, an average of 6 weeks
    Title
    Arterial Stiffness
    Description
    Comparing leg strength before and after intervention
    Time Frame
    through study completion, an average of 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years old History of lower limb unilateral transfemoral amputation. At least two years post lower limb amputation Able to ambulate independently without the use of aids (i.e., walking cane). Able to walk at least 10 minutes continuously without stopping. Has a safe residuum with no open wounds on either the residual or intact limb. Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study. Exclusion Criteria: Younger than 18 years old. Inability to give informed consent. Neurological disorder that affects gait. Participants with significant metal (greater than one orthopaedic screw) in either the residual limb or the sound/intact limb Participants who begin taking medications or change dosage of medications that could affect gait, balance, and cardiovascular function during the course of the study. Currently pregnant (or intend to become pregnant while participating in study). History of any condition where fatiguing contractions or resisted leg contractions are contraindicated. Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg). History of uncontrolled hypertension. History of heart failure. Head injury within the previous 6 months. Seizure disorder. History of vascular disease. History of thrombosis. History of sickle cell trait. History of genetic disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lindsay Slater
    Phone
    3123558965
    Email
    slaterlv@uic.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lindsay Slater
    Organizational Affiliation
    University of Illinois at Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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