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The objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (FES) of the lower leg to improve gait in people with foot drop.
Adaptive, current-steering FES enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. All participants will receive adaptive FES of the dorsiflexors and evertors during back-to-back walking sets. Participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). The primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. Secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional electrical stimulation in individuals with foot drop | Experimental | Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cionic Neural Sleeve | Device | Adaptive, functional electrical stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Dorsiflexion at Heel Strike | Dorsiflexion measured via inertial measurement unit (IMU) sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe. | 60 minutes |
| Mean Ankle Inversion During Swing Phase | Ankle inversion measured via IMU sensors placed on the foot and lower leg, measured in degrees. Swing phase is determined from pressure sensors in the shoe | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Foot Angle at Heel Strike | Foot angle measured via IMU sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe. | 60 minutes |
| Mean Heel-Toe Time as a Percent of Gait Cycle |
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Inclusion Criteria:
Adults aged 18-70
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cionic, Inc. | San Francisco | California | 94133 | United States | ||
| Cleveland State University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Electrical Stimulation in Individuals With Foot Drop | Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Electrical Stimulation in Individuals With Foot Drop | Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Dorsiflexion at Heel Strike | Dorsiflexion measured via inertial measurement unit (IMU) sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe. | Posted | Mean | 95% Confidence Interval | degrees | 60 minutes |
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1 year
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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 | Functional Electrical Stimulation in Individuals With Foot Drop | Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction |
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This study did not include the collection of certain traditional gait analysis metrics including spatial measures like gait speed and stride length as we relied solely on the on-body device for all data collection and metric extraction. Additionally, we were not able to compare functional electrical stimulation treatment impacts relative to standard of care, i.e. ankle-foot orthosis, in a randomized control trial (RCT). An RCT remains a future research study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Webster, Clinical Operations Manager | Cionic | 9257886649 | rebecca@cionic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2021 | Jul 12, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2021 | Aug 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020427 | Peroneal Neuropathies |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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A one-group, pre-test post-test study.
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Time of heel-toe, or single-side heel strike to toe strike measured by percent of gait, where 0% represents heel strike and 100% is the next heel strike. Heel strike assessed by pressure sensors placed in the shoe.
| 60 minutes |
| Cleveland |
| Ohio |
| 44115 |
| United States |
| Withdrawal by Subject |
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| Physiological Complications |
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| Other Reason |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
|
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| Primary | Mean Ankle Inversion During Swing Phase | Ankle inversion measured via IMU sensors placed on the foot and lower leg, measured in degrees. Swing phase is determined from pressure sensors in the shoe | Posted | Mean | 95% Confidence Interval | degrees | 60 minutes |
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|
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| Secondary | Mean Foot Angle at Heel Strike | Foot angle measured via IMU sensors placed on the foot and lower leg, measured in degrees. Heel strike is determined from pressure sensors in the shoe. | Posted | Mean | 95% Confidence Interval | degrees | 60 minutes |
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| Secondary | Mean Heel-Toe Time as a Percent of Gait Cycle | Time of heel-toe, or single-side heel strike to toe strike measured by percent of gait, where 0% represents heel strike and 100% is the next heel strike. Heel strike assessed by pressure sensors placed in the shoe. | Posted | Mean | 95% Confidence Interval | percentage of gait cycle | 60 minutes |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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