Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Stroke Clinical Trial

Official title:

Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00864708
• Other study ID #: B3252-R
• Secondary ID: B3513R
• Status: Terminated
• Phase: N/A
• First received: March 17, 2009
• Last updated: May 7, 2014
• Start date: December 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.

Description:

Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment.

Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Sufficient endurance to participate in rehabilitation sessions.

• Medically Stable

• Age >21 years.

• Inability to perform normal ankle coordinated gait components.

• Participants should be able to walk and keep balance without physical assistance from another person

Exclusion Criteria:

• Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy.

• Lower motor neuron damage or radiculopathy

• Allergy or contraindication to anesthesia, Versed, (or comparable substitute.

• Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device.

• Pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Fully Implanted FES system to assist patient with gait component practice

Locations

Country	Name	City	State
United States	VA Medical Center, Cleveland	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	The Alfred E. Mann Foundation for Scientific Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Endurance (6MWT)	The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure.	Day 1 and at 3 months, following treatment	No
Primary	Kinematic Gait Measures	assessment of the lower limb kinematics during ambulation at chosen speed.	Day 1 and at 3 months, following treatment	No
Secondary	Fugl-Meyer Lower Extremity Score	Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal).	Day 1 and at 3 months, following treatment	No
Secondary	Ashworth Scale	The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40)	Day 1 and at 3 months, following treatment	No
Secondary	Stroke Impact Scale (SIS)	The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295).	Day 1 and at 3 months, following treatment	No
Secondary	Manual Muscle Testing (MMT)	This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score)	Day 1 and at 3 months, following treatment	No