Trial Outcomes & Findings for BCI-FES Therapy for Stroke Rehabilitation (NCT NCT04279067)
NCT ID: NCT04279067
Last Updated: 2026-02-10
Results Overview
Gait velocity will be assessed by measuring the time to traverse the middle 6 m of a 10-m walkway (5 repetitions/assessment). Scores are reported in meters/second with higher scores indicating better function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline to End of Therapy (4 weeks after initiation of therapy)
Results posted on
2026-02-10
Participant Flow
Participant milestones
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
COMPLETED
|
29
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BCI-FES Therapy for Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
Dose-and Intensity-matched Physiotherapy
n=30 Participants
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 Participants
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.30 years
STANDARD_DEVIATION 12.85 • n=1581 Participants
|
60.03 years
STANDARD_DEVIATION 10.54 • n=41 Participants
|
59.19 years
STANDARD_DEVIATION 11.65 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=1581 Participants
|
8 Participants
n=41 Participants
|
25 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=1581 Participants
|
24 Participants
n=41 Participants
|
37 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=1581 Participants
|
11 Participants
n=41 Participants
|
23 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1581 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=1581 Participants
|
18 Participants
n=41 Participants
|
35 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1581 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=1581 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=1581 Participants
|
26 Participants
n=41 Participants
|
48 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1581 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=4626 Participants
|
|
Gait Velocity
|
0.38 m/s
STANDARD_DEVIATION 0.26 • n=1581 Participants
|
0.38 m/s
STANDARD_DEVIATION 0.21 • n=41 Participants
|
0.38 m/s
STANDARD_DEVIATION 0.23 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline to End of Therapy (4 weeks after initiation of therapy)Population: Difference due to dropouts.
Gait velocity will be assessed by measuring the time to traverse the middle 6 m of a 10-m walkway (5 repetitions/assessment). Scores are reported in meters/second with higher scores indicating better function.
Outcome measures
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 Participants
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 Participants
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
Gait Velocity
Baseline
|
0.38 m/s
Standard Deviation 0.21
|
0.38 m/s
Standard Deviation 0.26
|
|
Gait Velocity
End of Therapy
|
0.46 m/s
Standard Deviation 0.23
|
0.45 m/s
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline and end of therapy (4 weeks after initiation of therapy)Population: Difference due to dropouts
The paretic foot will be placed in a dangling, subtalar neutral position idling, while the tibia is perpendicular to the ground and the femur horizontal to the ground. A goniometer will be used to measure the maximum dorsiflexion angle, in degrees. 0 degrees indicates a neutral ankle position (foot horizontal to the ground, while tibia is perpendicular to the ground). Positive degrees indicate a maximum dorsiflexion angle above the neutral position, while negative degrees indicates a maximum angle below the neutral position (a larger, more positive measure indicates higher function).
Outcome measures
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 Participants
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 Participants
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
Dorsiflexion Range of Motion
Baseline
|
-12.54 degrees
Standard Deviation 13.78
|
-16.67 degrees
Standard Deviation 15.78
|
|
Dorsiflexion Range of Motion
End of Therapy
|
-10.05 degrees
Standard Deviation 13.07
|
-13.94 degrees
Standard Deviation 15.74
|
SECONDARY outcome
Timeframe: Baseline to End of Therapy (4 weeks after initiation of therapy)Population: Difference due to drop outs.
The distance walked over 6 minutes. Score is reported in meters and higher score indicates better function.
Outcome measures
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 Participants
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 Participants
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
Gait Endurance (Six Minute Walk Test: 6MWT)
Baseline
|
101.08 m
Standard Deviation 57.16
|
105.74 m
Standard Deviation 75.60
|
|
Gait Endurance (Six Minute Walk Test: 6MWT)
End of Therapy
|
118.19 m
Standard Deviation 60.91
|
118.83 m
Standard Deviation 85.38
|
SECONDARY outcome
Timeframe: Baseline to End of Therapy (4 weeks after initiation of therapy)Population: Difference due to drop outs.
Rate of falls experienced by subjects
Outcome measures
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 Participants
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 Participants
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
Fall Frequency
Baseline
|
0.11 falls/week
Standard Deviation 0.32
|
0.08 falls/week
Standard Deviation 0.27
|
|
Fall Frequency
End of Therapy
|
0 falls/week
Standard Deviation 0
|
0 falls/week
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline to End of Therapy (4 weeks after initiation of therapy)Population: Difference in subjects due to dropouts.
Subjects will undergo 64-channel EEG recording as they engage in 100 alternating 10-s long epochs of idling and attempted dorsiflexion. The EEG modulation, defined as the change in alpha (8-12 Hz) and beta (13-30 Hz) band power during attempted dorsiflexion (compared to idling) will be calculated and averaged over all epochs and across all channels. Change in EEG alpha and beta band power will be express as percentage with respect to the idle state. Specifically, the change in the Channel Cz will be reported given its primary salience to attempted dorsiflexion.
Outcome measures
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 Participants
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform \~10 BCI-FES runs (5 min/run). A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 Participants
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
EEG Map (Electroencephalogram)
Baseline
|
-31.73 % of EEG alpha/beta power change
Standard Deviation 18.55
|
-39.48 % of EEG alpha/beta power change
Standard Deviation 18.84
|
|
EEG Map (Electroencephalogram)
End of Therapy
|
-38.74 % of EEG alpha/beta power change
Standard Deviation 25.10
|
-36.33 % of EEG alpha/beta power change
Standard Deviation 22.10
|
Adverse Events
BCI-FES Dorsiflexion Therapy With Physiotherapy
Serious events: 7 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose-and Intensity-matched Physiotherapy
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 participants at risk
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform 20-25 BCI-FES runs. A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 participants at risk
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
Nervous system disorders
Severe adverse events (unrelated to study procedures)
|
3.1%
1/32 • Baseline to End of 3-month post intervention follow up
|
6.7%
2/30 • Baseline to End of 3-month post intervention follow up
|
|
General disorders
Falls with injury (unrelated to study procedures)
|
6.2%
2/32 • Baseline to End of 3-month post intervention follow up
|
0.00%
0/30 • Baseline to End of 3-month post intervention follow up
|
|
Cardiac disorders
Cardiac events
|
9.4%
3/32 • Baseline to End of 3-month post intervention follow up
|
3.3%
1/30 • Baseline to End of 3-month post intervention follow up
|
|
Musculoskeletal and connective tissue disorders
Orthopedic Injuries
|
3.1%
1/32 • Baseline to End of 3-month post intervention follow up
|
0.00%
0/30 • Baseline to End of 3-month post intervention follow up
|
Other adverse events
| Measure |
BCI-FES Dorsiflexion Therapy With Physiotherapy
n=32 participants at risk
Subjects will undergo placement of an EEG cap using standard technique connected to our custom BCI system. Subjects will provide 5 min of training EEG data as they engage in alternating epochs of idling and attempted foot dorsiflexion (of the paretic side). In the online phase, the subjects will perform 20-25 BCI-FES runs. A total of 12 sessions will be performed at a rate of 3x/week (over 4 weeks). Each BCI-FES therapy session will be followed by 1 hour of conventional physiotherapy.
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises.
|
Dose-and Intensity-matched Physiotherapy
n=30 participants at risk
Conventional Physical Therapy: This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
In the dose-matched control group (Group 2), it will be 2 hours/session.
|
|---|---|---|
|
General disorders
Pain
|
6.2%
2/32 • Baseline to End of 3-month post intervention follow up
|
0.00%
0/30 • Baseline to End of 3-month post intervention follow up
|
|
Musculoskeletal and connective tissue disorders
Orthopedic Injury
|
3.1%
1/32 • Baseline to End of 3-month post intervention follow up
|
6.7%
2/30 • Baseline to End of 3-month post intervention follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place