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Functional Electrical Stimulation for Footdrop in Hemiparesis

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Odstock Dropped-Foot Stimulator (ODFS)
Conventional Standard of Care
Traditional Physical Therapy Treatment
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring hemiplegia, hemiparesis, stroke, foot-drop, electrical stimulation, ankle-foot-orthosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke Age: 18-80 years Unilateral hemiparesis Medically stable Sufficient endurance & motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO Berg Balance Scale score of 24 or greater without any assistive devices Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES If using an AFO, willing to terminate its use and comply with study requirements Exclusion Criteria: Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator Absent sensation of the affected lower 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 other implanted electronic systems Pregnant women Uncontrolled seizure disorder Parkinson's Disease Spinal cord injury Traumatic brain injury with evidence of motor weakness Multiple sclerosis Fixed ankle plantar flexor contracture Peroneal nerve injury at the fibular head as the cause of foot-drop Uncompensated hemineglect Severely impaired cognition and communication Painful hypersensitivity to NMES of the common peroneal nerve Inadequate social support (potential unlikeliness to comply with treatment & follow-up) History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ODFS

Standard of Care (inc. AFO)

Arm Description

Odstock Dropped-Foot Stimulator (ODFS)

Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) [Traditional Physical Therapy Treatment]

Outcomes

Primary Outcome Measures

Fugl-Meyer Motor Assessment (FMA)
Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).

Secondary Outcome Measures

Steps Per Minute
The number of steps taken by participants in one minute
Modified Emory Functional Ambulation Profile(mEFAP)
The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the "timed up-and-go" test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.
Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales. Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245.
Gait Speed

Full Information

First Posted
September 2, 2005
Last Updated
May 29, 2018
Sponsor
MetroHealth Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT00148343
Brief Title
Functional Electrical Stimulation for Footdrop in Hemiparesis
Official Title
Functional Electrical Stimulation for Footdrop in Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2, 2010 (Actual)
Study Completion Date
August 2, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this research is to determine if electrical stimulation can improve the strength and coordination of the lower limb muscles, and the walking ability of stroke survivors. The knowledge gained from this study may lead to enhancements in the quality of life of stroke survivors by improving their neurological recovery and mobility. The results may lead to substantial changes in the standard of care for the treatment of lower limb hemiparesis after stroke.
Detailed Description
Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase of gait, and ankle instability during stance phase, are important gait abnormalities that contribute to reduced mobility among stroke survivors. In the United States, the standard of care in addressing these deficits is the custom molded ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor relearning after stroke. Motor relearning is defined as the reacquisition of motor ability after central nervous system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term, it is possible that it also inhibits recovery in the long-term. Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation. However, there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators. Thus, the primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with conventional standard of care (which may include an AFO). Subjects will be treated for 12 weeks and followed for a total of another 6 months. This project will determine the effectiveness of peroneal nerve stimulation in facilitating motor relearning and improving the mobility and quality of life of stroke survivors. This proposed approach is expected to improve patient outcome and challenge the present clinical paradigm of prescribing AFOs for stroke survivors with foot-drop.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
hemiplegia, hemiparesis, stroke, foot-drop, electrical stimulation, ankle-foot-orthosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ODFS
Arm Type
Experimental
Arm Description
Odstock Dropped-Foot Stimulator (ODFS)
Arm Title
Standard of Care (inc. AFO)
Arm Type
Active Comparator
Arm Description
Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) [Traditional Physical Therapy Treatment]
Intervention Type
Device
Intervention Name(s)
Odstock Dropped-Foot Stimulator (ODFS)
Intervention Description
Device implementation & use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
Intervention Type
Other
Intervention Name(s)
Conventional Standard of Care
Intervention Description
Conventional standard of care (which may include implementation & use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
Intervention Type
Procedure
Intervention Name(s)
Traditional Physical Therapy Treatment
Intervention Description
Traditional physical therapy treatment for 12 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Motor Assessment (FMA)
Description
Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).
Time Frame
Weeks 0, 12, 24, 36
Secondary Outcome Measure Information:
Title
Steps Per Minute
Description
The number of steps taken by participants in one minute
Time Frame
Weeks 0, 12, 24, 36
Title
Modified Emory Functional Ambulation Profile(mEFAP)
Description
The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the "timed up-and-go" test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.
Time Frame
Weeks 0, 12, 24, 36
Title
Stroke-Specific Quality of Life Scale (SS-QOL)
Description
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales. Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245.
Time Frame
Weeks 0, 12, 24, 36
Title
Gait Speed
Time Frame
baseline, 12, 24 and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke Age: 18-80 years Unilateral hemiparesis Medically stable Sufficient endurance & motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO Berg Balance Scale score of 24 or greater without any assistive devices Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES If using an AFO, willing to terminate its use and comply with study requirements Exclusion Criteria: Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator Absent sensation of the affected lower 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 other implanted electronic systems Pregnant women Uncontrolled seizure disorder Parkinson's Disease Spinal cord injury Traumatic brain injury with evidence of motor weakness Multiple sclerosis Fixed ankle plantar flexor contracture Peroneal nerve injury at the fibular head as the cause of foot-drop Uncompensated hemineglect Severely impaired cognition and communication Painful hypersensitivity to NMES of the common peroneal nerve Inadequate social support (potential unlikeliness to comply with treatment & follow-up) History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Chae, MD
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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9360032
Citation
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Links:
URL
http://fescenter.org/index.php
Description
Cleveland FES Center

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Functional Electrical Stimulation for Footdrop in Hemiparesis

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