Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

NCT00864708 | Terminated Results DMC

• 2 other identifiers: B3252-RB3513R
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• Kinematic Gait Measures

  assessment of the lower limb kinematics during ambulation at chosen speed.

  Day 1 and at 3 months, following treatment

Secondary Outcomes (4)

• Fugl-Meyer Lower Extremity Score

  Day 1 and at 3 months, following treatment

• Ashworth Scale

  Day 1 and at 3 months, following treatment

• Stroke Impact Scale (SIS)

  Day 1 and at 3 months, following treatment

• Manual Muscle Testing (MMT)

  Day 1 and at 3 months, following treatment

Study Arms (1)

Arm 1

EXPERIMENTAL

radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Interventions

radio frequency-controlled (RF) Microstimulator (RFM) Gait System DEVICE

Fully Implanted FES system to assist patient with gait component practice

Arm 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• The Alfred E. Mann Foundation for Scientific Research: collaborator

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study sponsor, Alfred Mann foundation (AMF) stopped study because "enrollment period/study duration has exceeded the AMF's timeline".

Results Point of Contact

• Title: Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence
• Organization: NF/SG VA Medical Center, Gainesville Florida

janis.daly@neurology.ufl.edu

(352) 376-1611

Study Officials

• Janis Daly, PhD MS

  VA Medical Center-Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 19, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-05

Locations

US (1)