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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: FES | Experimental | Case-control study: pre- and post-stimulation (FES). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES | Device | Surface stimulation to contract the muscles in the lower extremity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Ankle Power | This is the peak ankle power during walking normalized by body weight. | Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study |
| Positive Ankle Work |
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Inclusion Criteria:
This study includes stroke survivors greater than 18 years of age, >180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
Exclusion Criteria:
In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Hardin van den Bogert, PhD MS | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
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Computational optimization was via tracking joint angles & ground reaction forces from an able walking subject.We optimized the hemiparetic (HP) subject's model to able data & their walking data producing optimization solutions for muscle activations in each case.The able subject was not considered enrolled,only 9 HPsubjects were actually enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: FES | Case-control study: pre- and post-stimulation (FES). FES: Surface stimulation to contract the muscles in the lower extremity |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The able-bodied participant was only used to develop the computational optimization and was not considered to be enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: FES | Case-control study: pre- and post-stimulation (FES). FES: Surface stimulation to contract the muscles in the lower extremity where subjects serve as their own control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Volitional and FES data available for participants with hemiparesis. | Posted | Mean | Standard Deviation | Joules/body mass in kilograms | pre-stimulation (volitional) and post-stimulation (FES), day of the study |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: FES | Case-control study: pre- and post-stimulation (FES). FES: Surface stimulation to contract the muscles in the lower extremity where subjects serve as their own control. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Hardin | Cleveland VAMC | 216-791-3800 | 4698 | Elizabeth.HardinvandenBogert@va.gov |
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| ID | Term |
|---|---|
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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This is the amount of positive work performed by the ankle during walking normalized by body mass.
| 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. | The is the magnitude of ground reaction force over time per step in the anterior direction during walking. | Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Arm 1: FES | Case-control study: pre- and post-stimulation (FES). FES: Surface stimulation to contract the muscles in the lower extremity |
|
|
| Secondary | Peak Ankle Power | This is the peak ankle power during walking normalized by body weight. | Volitional and FES data available for participants with hemiparesis. | Posted | Mean | Standard Deviation | Watts/body mass in kilograms | Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study |
|
|
|
| Secondary | Positive Ankle Work | This is the amount of positive work performed by the ankle during walking normalized by body mass. | Volitional and FES data available for participants with hemiparesis. | Posted | Mean | Standard Deviation | Joules/body mass in kilograms | Same day; pre-stimulation (volitional) and post-stimulation (FES), day of the study |
|
|
|
| Secondary | 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. | Volitional and FES data available for participants with hemiparesis. | Posted | Mean | Standard Deviation | Newtons*seconds/body mass in kilograms | Same day: pre-stimulation (volitional) and post-stimulation (FES), day of the study |
|
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| 0 |
| 9 |
| 0 |
| 9 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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