Neural Prostheses and Gait Performance: Model-Based Strategies

NCT00991406 | Completed Results DMC

• 1 other identifier: B4668-R
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability. FES involves applying small electric currents to the nerves, which cause the muscles to contract. FES research projects vary from simple investigations of the therapeutic effects of exercise on muscle function and skin health, to more complex studies of functional movements such as standing or walking.

Conditions

Hemiplegia

Keywords

Electric Stimulation; Hemiplegia; walking

Outcome Measures

Primary Outcomes (1)

• Walking Stability and Speed

  This was a feasibility study of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. We developed computer models and walking simulations of hemiplegic gait from 8 subjects. We related the model results (muscle activations) to the optimized data collected from hemiplegic subjects \& calculated the FES pattern to be delivered in 2 forms (open loop \& foot switch triggered). The primary outcome measure turned out to be the feasibility of the methods because after developing our computer modeling and computational optimization framework we could only test walking with the 2 forms of FES at the same preferred walking speed on a treadmill. Thus, the simulated walking speed and the real walking speed pre and post FES turned out to be the same. Walking stability was measured with variability in work performed at the ankle. The additional volitional and FES biomechanical data that were measured are listed in the secondary measures.

  pre-stimulation (volitional) and post-stimulation (FES), day of the study

Secondary Outcomes (3)

• Peak Ankle Power

  Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study

• Positive Ankle Work

  Same day; pre-stimulation (volitional) and post-stimulation (FES), day of the study

• The Impulse of the Anterior Ground Reaction Force Normalized by Body Mass.

  Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study

Study Arms (1)

Arm 1: FES

EXPERIMENTAL

Case-control study: pre- and post-stimulation (FES).

Device: FES

Interventions

FES DEVICE

Surface stimulation to contract the muscles in the lower extremity

Arm 1: FES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study includes stroke survivors greater than 18 years of age, \>180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
• Unilateral hemiparesis with sufficient endurance and motor ability to ambulate \>30 feet continuously without an AFO requiring no more than 25% physical help
• Berg Balance Scale score \>23 without assistive devices
• Standing ankle dorsiflexion strength of \<4/5
• Foot-drop during ambulation with gait instability or inefficient gait defined as supervision need
• Possible use of physical assistance or assistive device (cane, walker)
• Evidence of foot-drop as seen by "dragging" or "catching" of affected toes during limb swing or circumducting affected limb
• Vaulting of the unaffected limb or hiking the affected hip to clear toes.
• Intact and electrically ex-citable lower motor neurons
• Ankle dorsiflexion to at least neutral while standing with electrical stimulation of common peroneal and tibial nerves without painful hypersensitivity to stimulation
• Adequate social support and stability
• Medically stable with intact skin in affected lower limb
• Willingness to comply during research procedures
• No systemic co-morbidities
• No history of potentially fatal cardiac arrhythmias i.e. ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation with hemodynamic instability

You may not qualify if:

• Requires an ankle foot orthosis (AFO) to prevent knee flexion collapse in stance
• Excessive edema of affected extremity
• Absent sensation in affected limb
• History of potentially fatal cardiac arrhythmias such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response, atrial fibrillation with hemodynamic instability
• Demand pacemakers or any implanted electronic systems
• Pregnancy
• Uncontrolled seizure disorder
• Ipsilateral lower limb lower motor neuron lesion
• Parkinson's disease
• Spinal cord injury
• Traumatic brain injury
• Multiple sclerosis
• Ankle plantar flexor contraction
• Severely impaired cognition and communication
• Painful hypersensitivity to neuromuscular stimulation of common peroneal nerve

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elizabeth Hardin
• Organization: Cleveland VAMC

Elizabeth.HardinvandenBogert@va.gov

216-791-3800

Study Officials

• Elizabeth C Hardin van den Bogert, PhD MS

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: 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: October 2, 2009
• First Posted: October 8, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2019-07

Locations

US (1)