Improving Ambulatory Community Access After Paralysis

NCT01570816 | Unknown Phase 1 DMC

• 2 other identifiers: 12004-H021I01RX000528-01A2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis

  Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.

  up to 36 months

Secondary Outcomes (1)

• Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation

  up to 36 months

Study Arms (1)

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

Device: IRS-8 (8 channel implanted receiver stimulator)

Interventions

IRS-8 (8 channel implanted receiver stimulator) DEVICE

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

Also known as: Implanted pulse generator for ambulation, Implanted FES system for lower extremities, Implated FES system for ambulation, FES system for walking, Implanted neuroprosthesis for gait correction, Gait correction in partial paralysis

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (3)

• Bailey SN, Hardin EC, Kobetic R, Boggs LM, Pinault G, Triolo RJ. Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury. J Rehabil Res Dev. 2010;47(1):7-16. doi: 10.1682/jrrd.2009.03.0034.

  PMID: 20437323 BACKGROUND

• Hardin E, Kobetic R, Murray L, Corado-Ahmed M, Pinault G, Sakai J, Bailey SN, Ho C, Triolo RJ. Walking after incomplete spinal cord injury using an implanted FES system: a case report. J Rehabil Res Dev. 2007;44(3):333-46. doi: 10.1682/jrrd.2007.03.0333.

  PMID: 18247230 BACKGROUND

• Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.

  PMID: 28899825 DERIVED

Related Links

• Cleveland FES center website

MeSH Terms

Conditions

Stroke; Muscle Weakness; Spinal Cord Injuries; Quadriplegia; Paraplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis

Study Officials

• Rudi Kobetic, MSBE

  Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M Lombardo, MPT

CONTACT

216-791-3800; llombardo@fescenter.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedical Engineer

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

US (1)