Back to resultsAugmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Primary Purpose
Foot Drop
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cionic Neural Sleeve
Sponsored by
About this trial
This is an interventional treatment trial for Foot Drop
Eligibility Criteria
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
Sites / Locations
- Cionic, Inc.
- Cleveland State University
Outcomes
Primary Outcome Measures
Dorsiflexion at heel strike measured in degrees
Measured by IMU sensors placed on the foot and lower leg, and heel strike is determined from pressure sensors in the shoe
Mean ankle inversion during swing phase measured in degrees
Measured by IMU sensors placed on the foot and lower leg, and swing is determined from pressure sensors in the shoe
Secondary Outcome Measures
Foot angle at heel strike measured in degrees
Measured by IMU sensors placed on the foot and lower leg, and heel strike is determined from pressure sensors in the shoe
Heel-toe Time measured in seconds
The duration between heel strike and toe strike measured by pressure sensors placed in the shoe
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05346640
Brief Title
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Official Title
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cionic, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Drop
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A one-group, pre-test post-test study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Cionic Neural Sleeve
Intervention Description
Adaptive, functional electrical stimulation
Primary Outcome Measure Information:
Title
Dorsiflexion at heel strike measured in degrees
Description
Measured by IMU sensors placed on the foot and lower leg, and heel strike is determined from pressure sensors in the shoe
Time Frame
60 minutes
Title
Mean ankle inversion during swing phase measured in degrees
Description
Measured by IMU sensors placed on the foot and lower leg, and swing is determined from pressure sensors in the shoe
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Foot angle at heel strike measured in degrees
Description
Measured by IMU sensors placed on the foot and lower leg, and heel strike is determined from pressure sensors in the shoe
Time Frame
60 minutes
Title
Heel-toe Time measured in seconds
Description
The duration between heel strike and toe strike measured by pressure sensors placed in the shoe
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cionic, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
Facility Name
Cleveland State University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation
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