Recruiting
Phase 1

Observational Study

Sponsor:

Louis Stokes VA Medical Center

Code:

NCT01570816

Conditions

Stroke

Partial Paralysis

Spinal Cord Injury

Tetraplegia

Quadriplegia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IRS-8 (8 channel implanted receiver stimulator)

Study Details

Brief summary:

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.

Conditions

Stroke

Partial Paralysis

Spinal Cord Injury

Tetraplegia

Quadriplegia

Study ID

NCT01570816

Start date

Apr, 2012

Status verified date

Mar, 2018

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures

Interventions

IRS-8 (8 channel implanted receiver stimulator)

Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities

Primary outcome measure

  • The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis [ Time Frame: up to 36 months ]

Central Contacts and Locations

Central contacts

Lisa M Lombardo, MPT

216-791-3800llombardo@fescenter.org

Locations

Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Lisa M Lombardo, MPT

216-791-3800llombardo@fescenter.org

Principal Investigator:

Rudi Kobetic, MSBE

More Information

Sponsor

Louis Stokes VA Medical Center

Last update posted

Mar 14, 2018

Last verified

Mar, 2018

Keywords

  • stroke
  • partial paralysis
  • gait correction
  • functional electrical stimulation
  • paraplegia
  • tetraplegia
  • spinal cord injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louis Stokes VA Medical Center on 2018-03-14.