Improving Ambulatory Community Access After Paralysis

Status unconfirmed · Phase 1

Conditions studied: Stroke, Partial Paralysis, Spinal Cord Injury, Tetraplegia, Quadriplegia

In brief

The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.

Key facts

Study ID

NCT01570816

Run by

Louis Stokes VA Medical Center

People needed

6

Starts

2012-04-01

Expected to finish

2021-07-01

Last updated by the study team

2018-03-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• problems walking because of paralysis for more than 6 months
• weak hip flexors and extensors or excessive tone
• weak ankle dorsiflexors (muscles bringing the foot up)
• weak plantar flexors (ankle muscles for push-off)
• foot drop that is causing "dragging" or "catching" toes during walking
• swinging the leg sideways or hiking the hip to clear affected leg during stepping
• endurance to walk at least 10 ft with minimal assistance
• hip extension range to neutral
• hip flexion range greater or equal to 90 degrees
• ankle range to neutral
• sufficient upper extremity function to use a walking aid
• muscles respond to electrical stimulation

You may not qualify if…

• cardiac arrythmias
• demand pacemaker
• pregnancy
• Parkinson's disease
• traumatic brain injury
• autoimmune deficiency
• uncontrolled diabetes
• significant edema of the affected limb
• active pressure ulcers or open wounds
• sepsis or an active infection
• severe osteoporosis
• uncontrolled seizures
• moderate depression

Where it is running

• Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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