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Neural Prostheses and Gait Performance: Model-Based Strategies

Primary Purpose

Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FES
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Electric Stimulation, Hemiplegia, walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
  • No psychological problems or chemical dependency
  • No acute medical complications such as depression or chronic anxiety requiring long term pharmacological therapy. Able-bodied controls must be of similar age, body mass and stature as those with hemiparesis and must be free of any medical and disabling orthopedic problems.

Exclusion Criteria:

In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:

  • 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
  • Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
  • History of botulinum toxin to the lower extremity within the prior three months.

Sites / Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: FES

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Peak Ankle Power
This is the peak ankle power during walking normalized by body weight.
Positive Ankle Work
This is the amount of positive work performed by the ankle during walking normalized by body mass.
The Impulse of the Anterior Ground Reaction Force Normalized by Body Mass.
The is the magnitude of ground reaction force over time per step in the anterior direction during walking.

Full Information

First Posted
October 2, 2009
Last Updated
July 18, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00991406
Brief Title
Neural Prostheses and Gait Performance: Model-Based Strategies
Official Title
Neural Prostheses and Gait Performance: Model-Based Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study aims 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 will be achieved through an analytical approach comprised of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. The investigators will develop a computer simulation of the dynamics of hemiplegic gait characterized by unilateral plantarflexor weakness. Then, the investigators will relate the results of the computer model results to real data collected from subjects with known plantarflexor weakness to provide a theoretical basis for improving gait efficiency and stability with FES.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Electric Stimulation, Hemiplegia, walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: FES
Arm Type
Experimental
Arm Description
Case-control study: pre- and post-stimulation (FES).
Intervention Type
Device
Intervention Name(s)
FES
Intervention Description
Surface stimulation to contract the muscles in the lower extremity
Primary Outcome Measure Information:
Title
Walking Stability and Speed
Description
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.
Time Frame
pre-stimulation (volitional) and post-stimulation (FES), day of the study
Secondary Outcome Measure Information:
Title
Peak Ankle Power
Description
This is the peak ankle power during walking normalized by body weight.
Time Frame
Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study
Title
Positive Ankle Work
Description
This is the amount of positive work performed by the ankle during walking normalized by body mass.
Time Frame
Same day; pre-stimulation (volitional) and post-stimulation (FES), day of the study
Title
The Impulse of the Anterior Ground Reaction Force Normalized by Body Mass.
Description
The is the magnitude of ground reaction force over time per step in the anterior direction during walking.
Time Frame
Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 No psychological problems or chemical dependency No acute medical complications such as depression or chronic anxiety requiring long term pharmacological therapy. Able-bodied controls must be of similar age, body mass and stature as those with hemiparesis and must be free of any medical and disabling orthopedic problems. Exclusion Criteria: In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following: 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 Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation History of botulinum toxin to the lower extremity within the prior three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Hardin van den Bogert, PhD MS
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neural Prostheses and Gait Performance: Model-Based Strategies

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