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

NCT05929508 | Recruiting

• 1 other identifier: 2023-0250
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Amputation of Lower Extremity

Outcome Measures

Primary Outcomes (5)

• Strength

  Comparing leg strength before and after intervention

  through study completion, an average of 6 weeks

• Gait

  Comparing leg strength before and after intervention

  through study completion, an average of 6 weeks

• Metabolics

  Comparing leg strength before and after intervention

  through study completion, an average of 6 weeks

• Daily Steps/Activity

  Comparing leg strength before and after intervention

  through study completion, an average of 6 weeks

• Arterial Stiffness

  Comparing leg strength before and after intervention

  through study completion, an average of 6 weeks

Study Arms (2)

Ischemic Preconditioning at High Pressure

ACTIVE COMPARATOR

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).

Other: Ischemic Preconditioning

Ischemic Preconditioning at Low Pressure

SHAM COMPARATOR

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).

Other: Ischemic Preconditioning

Interventions

Ischemic Preconditioning OTHER

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).

Ischemic Preconditioning at High Pressure; Ischemic Preconditioning at Low Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

UIC Physical Therapy Faculty Practice

Chicago, Illinois, 60608, United States

RECRUITING

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Lindsay Slater

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Slater

CONTACT

3123558965; slaterlv@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 3, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)