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

Conditions

• Traumatic Amputation of Lower Extremity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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).

Study Details

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.

Key Dates

Start date

Apr 1, 2024

Status verified

Nov 2025

Primary completion

Jun 1, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

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).

Primary Outcome Measure

Strength [ Time Frame: through study completion, an average of 6 weeks ]

Central Contacts

• Lindsay Slater
  3123558965
  [email protected]

Locations (1)

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