Trial Outcomes & Findings for Augmenting Gait in a Population Exhibiting Foot Drop With Adaptive Functional Electrical Stimulation (NCT NCT05346640)

Last Updated: 2024-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

60 minutes

Results posted on

2024-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	60
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	14
Overall Study Protocol Violation	4
Overall Study Withdrawal by Subject	2
Overall Study Physiological Complications	3
Overall Study Other Reason	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Functional Electrical Stimulation in Individuals With Foot Drop n=32 Participants Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction
Age, Categorical <=18 years	0 Participants n=32 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=32 Participants
Age, Categorical >=65 years	9 Participants n=32 Participants
Age, Continuous	60.1 years STANDARD_DEVIATION 11.1 • n=32 Participants
Age, Customized 30-39 years	2 Participants n=32 Participants
Age, Customized 40-49 years	3 Participants n=32 Participants
Age, Customized 50-59 years	10 Participants n=32 Participants
Age, Customized 60-69 years	11 Participants n=32 Participants
Age, Customized 70-79 years	5 Participants n=32 Participants
Age, Customized 80-89 years	1 Participants n=32 Participants
Sex: Female, Male Female	18 Participants n=32 Participants
Sex: Female, Male Male	14 Participants n=32 Participants
Diagnosis Stroke	20 Participants n=32 Participants
Diagnosis Multiple Sclerosis	8 Participants n=32 Participants
Diagnosis Cerebral Palsy	1 Participants n=32 Participants
Diagnosis Spinal Injury	2 Participants n=32 Participants
Diagnosis Idiopathic	1 Participants n=32 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Functional Electrical Stimulation in Individuals With Foot Drop n=32 Participants Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction
Mean Dorsiflexion at Heel Strike	5.2 degrees Interval 3.5 to 6.8

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Functional Electrical Stimulation in Individuals With Foot Drop n=32 Participants Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction
Mean Ankle Inversion During Swing Phase	-3.6 degrees Interval -5.3 to -1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Functional Electrical Stimulation in Individuals With Foot Drop n=32 Participants Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction
Mean Foot Angle at Heel Strike	5.5 degrees Interval 3.9 to 7.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Functional Electrical Stimulation in Individuals With Foot Drop n=32 Participants Comparison of kinematics in stimulated and unstimulated gait using functional electrical stimulation in individuals with foot drop as a result of a neurological dysfunction
Mean Heel-Toe Time as a Percent of Gait Cycle	3.4 percentage of gait cycle Interval 1.9 to 4.8

Adverse Events

Functional Electrical Stimulation in Individuals With Foot Drop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebecca Webster, Clinical Operations Manager

Cionic

Phone: 9257886649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place