Improving Ambulatory Community Access After Paralysis

Stroke Clinical Trial

Official title:

Improving Ambulatory Community Access After Paralysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01570816
• Other study ID #: 12004-H02
• Secondary ID: 1I01RX000528-01A
• Status: Recruiting
• Phase: Phase 1
• First received: April 2, 2012
• Last updated: March 12, 2018
• Start date: April 2012
• Est. completion date: July 2021

Study information

• Verified date: March 2018
• Source: Louis Stokes VA Medical Center
• Contact: Lisa M Lombardo, MPT
• Phone: 216-791-3800
• Email: llombardo[@]fescenter.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Paralysis
• Paresis
• Partial Paralysis
• Quadriplegia
• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke
• Tetraplegia

Intervention

Device:
• IRS-8 (8 channel implanted receiver stimulator)
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities

Locations

Country	Name	City	State
United States	Louis Stokes Cleveland Dept. of Veterans Affairs Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Louis Stokes VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without accelerometer triggered stepping to determine if individuals are able to adjust to environmental circumstances and situations encountered in community ambulation.	up to 36 months

External Links

•   Cleveland FES center website