Recruiting

Mobility Improvement

Sponsor:

University of Illinois at Chicago

Code:

NCT05929508

Conditions

Traumatic Amputation of Lower Extremity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ischemic Preconditioning

Study Details

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

Study ID

NCT05929508

Start date

Apr 1, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Ischemic Preconditioning at High Pressure

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).

sham comparator: Ischemic Preconditioning at Low Pressure

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).

Interventions

Ischemic Preconditioning

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

  • Strength [ Time Frame: through study completion, an average of 6 weeks ]
  • Gait [ Time Frame: through study completion, an average of 6 weeks ]
  • Metabolics [ Time Frame: through study completion, an average of 6 weeks ]
  • Daily Steps/Activity [ Time Frame: through study completion, an average of 6 weeks ]
  • Arterial Stiffness [ Time Frame: through study completion, an average of 6 weeks ]

Central Contacts and Locations

Central contacts

Lindsay Slater

3123558965slaterlv@uic.edu

Locations

UIC Physical Therapy Faculty Practice

Recruiting

Chicago, Illinois, United States, 60608

Contacts

Lindsay Slater, PhD

3123558965slaterlv@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Nov 17, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-11-17.