Foot Drop
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICECionic Neural Sleeve
Adaptive, functional electrical stimulation
Sponsors
Cionic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A one-group, pre-test post-test study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18-70 * Lower extremity impairment that makes walking difficult or uncomfortable * Capable of sitting, standing, and walking independently or with assistance * Able to walk at least 50 feet independently or with assistance * Able to understand and follow basic instructions in English
Exclusion criteria
* Have non-reversible damage to the peripheral nervous system * Have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices * Have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent * Have lower motor neuron disease or injury that may impair response to stimulation * Are pregnant * Are under the age of 18 years old * Have skin conditions of the affected lower limb, including cuts, burns or lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Dorsiflexion at Heel Strike | 60 minutes | 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. |
| Mean Ankle Inversion During Swing Phase | 60 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Foot Angle at Heel Strike | 60 minutes | 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. |
| Mean Heel-Toe Time as a Percent of Gait Cycle | 60 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Other Reason | 3 |
| Overall Study | Physiological Complications | 3 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Functional Electrical Stimulation in Individuals With Foot Drop | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 9 Participants | — |
| Age, Categorical Between 18 and 65 years | 23 Participants | — |
| Age, Continuous | 60.1 years STANDARD_DEVIATION 11.1 | — |
| Age, Customized 30-39 years | 2 Participants | — |
| Age, Customized 40-49 years | 3 Participants | — |
| Age, Customized 50-59 years | 10 Participants | — |
| Age, Customized 60-69 years | 11 Participants | — |
| Age, Customized 70-79 years | 5 Participants | — |
| Age, Customized 80-89 years | 1 Participants | — |
| Diagnosis Cerebral Palsy | 1 Participants | — |
| Diagnosis Idiopathic | 1 Participants | — |
| Diagnosis Multiple Sclerosis | 8 Participants | — |
| Diagnosis Spinal Injury | 2 Participants | — |
| Diagnosis Stroke | 20 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Electrical Stimulation in Individuals With Foot Drop | Mean Ankle Inversion During Swing Phase | -3.6 degrees |
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.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Electrical Stimulation in Individuals With Foot Drop | Mean Dorsiflexion at Heel Strike | 5.2 degrees |
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.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Electrical Stimulation in Individuals With Foot Drop | Mean Foot Angle at Heel Strike | 5.5 degrees |
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.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Electrical Stimulation in Individuals With Foot Drop | Mean Heel-Toe Time as a Percent of Gait Cycle | 3.4 percentage of gait cycle |