Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07664995
Status
Not Yet Recruiting

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Conditions

  • Below Knee Amputation
  • Lower Limb Amputation Above Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood pressure cuff — DEVICE
    A blood pressure cuff will be used for ischemic conditioning, which is a non-invasive intervention that involves episodes of muscle ischemia (restriction of blood flow) followed by reperfusion (restoration of blood flow).
  • Neuromuscular Electrical Stimulation — DEVICE
    Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.

Study Details

The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior in those with limb loss. The main questions this trial aims to answer are: Does neuromuscular electrical stimulation improve muscle strength and gait behavior in people who have a leg amputation? Does neuromuscular electrical stimulation boost the effects of ischemic conditioning on muscle strength and gait behavior in people who have a leg amputation? Researchers will compare the effects of neuromuscular electrical stimulation to ischemic conditioning to see if there are any significant differences between the impacts of each intervention. Also, researchers will use both interventions together to see if the interventions can boost each other's positive impacts on walking and function in people with leg amputation. Participants will: * Do ischemic conditioning OR neuromuscular electrical stimulation OR both interventions at home every other day for 2 weeks * Visit the laboratory before and after completing interventions for the tests * Visit the laboratory one week after the post intervention visit for follow-up tests

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Aug 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ischemic Conditioning
  • Experimental: Neuromuscular Electrical Stimulation
  • Experimental: Neuromuscular Electrical Stimulation + Ischemic Conditioning

Primary Outcome Measure

Change from baseline in the self-selected gait speed (m/s) at week 3 and 4 [ Time Frame: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60607-

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