Trial Outcomes & Findings for Neuromodulation and Dynamic Balance in Stroke (NCT NCT05135533)
NCT ID: NCT05135533
Last Updated: 2026-08-13
Results Overview
Self-selected comfortable walking overground walking speed in cm/s.
COMPLETED
NA
53 participants
Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeks
2026-08-13
Participant Flow
Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results.
Participant milestones
| Measure |
Portable Neuromodulation Stimulator
All participants will receive balance, gait and breathing exercises. In addition to the exercises, the Portable Neuromodulation Stimulator active group members will receive perceivable electrical stimulation felt as a moderately intense tingling sensation. Each participant will be issued their own PoNS device.
|
Sham
All participants will receive balance, gait and breathing exercises. In addition to the exercises, the sham group will wear the mouthpiece and receive a non-perceivable stimulus. Each participant will be issued their own PoNS device.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results reported below.
Baseline characteristics by cohort
| Measure |
Portable Neuromodulation Stimulator
n=25 Participants
All participants will receive balance, gait and breathing exercises. In addition to the exercises, the Portable Neuromodulation Stimulator active group members will receive perceivable electrical stimulation felt as a moderately intense tingling sensation. Each participant will be issued their own PoNS device.
|
Sham
n=21 Participants
All participants will receive balance, gait and breathing exercises. In addition to the exercises, the sham group will wear the mouthpiece and receive a non-perceivable stimulus. Each participant will be issued their own PoNS device.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.76 years
STANDARD_DEVIATION 9.31 • n=1 Participants
|
56.67 years
STANDARD_DEVIATION 8.2 • n=1 Participants
|
59.98 years
STANDARD_DEVIATION 9.24 • n=1 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=1 Participants
|
7 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=1 Participants
|
14 Participants
n=1 Participants
|
27 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
42 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Gait Speed
|
66.68 cm/s
STANDARD_DEVIATION 27.06 • n=1 Participants • Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results reported below.
|
64.71 cm/s
STANDARD_DEVIATION 37.28 • n=1 Participants • Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results reported below.
|
65.78 cm/s
STANDARD_DEVIATION 31.76 • n=1 Participants • Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results reported below.
|
|
Functional Gait Assessment
|
12.60 score on scale
STANDARD_DEVIATION 5.35 • n=1 Participants
|
12.71 score on scale
STANDARD_DEVIATION 6.28 • n=1 Participants
|
12.65 score on scale
STANDARD_DEVIATION 5.72 • n=1 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, midpoint at four weeks, and post-treatment at 12 weeksPopulation: Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization. As they did not receive an allocated intervention, they are not included in the arm-level results reported below.
Self-selected comfortable walking overground walking speed in cm/s.
Outcome measures
| Measure |
Portable Neuromodulation Stimulator
n=25 Participants
The PoNS group received electrical stimulation.
|
Sham
n=21 Participants
The Sham group did not receive electrical stimulation.
|
|---|---|---|
|
Change in Gait Speed
Visit 1 (Baseline)
|
66.68 cm/s
Standard Deviation 27.06
|
64.71 cm/s
Standard Deviation 37.28
|
|
Change in Gait Speed
Visit 2 (Week 4)
|
69.58 cm/s
Standard Deviation 27.75
|
69.33 cm/s
Standard Deviation 37.07
|
|
Change in Gait Speed
Visit 3 (Week 12 - Post)
|
62.96 cm/s
Standard Deviation 30.03
|
68.69 cm/s
Standard Deviation 41.01
|
PRIMARY outcome
Timeframe: Pre-treatment, midpoint at four weeks, and post-treatment at at 12 weeksPopulation: Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization. As they did not receive an allocated intervention, they are not included in the arm-level results reported below.
Functional Gait Assessment (FGA) assesses stability during walking. The score ranges between 0 and 30 with lower scores indicative of poor dynamic balance.
Outcome measures
| Measure |
Portable Neuromodulation Stimulator
n=25 Participants
The PoNS group received electrical stimulation.
|
Sham
n=21 Participants
The Sham group did not receive electrical stimulation.
|
|---|---|---|
|
Change in Balance
Visit 1 (Baseline)
|
12.60 score on scale
Standard Deviation 5.35
|
12.71 score on scale
Standard Deviation 6.28
|
|
Change in Balance
Visit 2 (Week 4)
|
15.77 score on scale
Standard Deviation 5.75
|
15.00 score on scale
Standard Deviation 6.75
|
|
Change in Balance
Visit 3 (Week 12 - Post)
|
16.42 score on scale
Standard Deviation 5.98
|
15.13 score on scale
Standard Deviation 7.12
|
Adverse Events
Portable Neuromodulation Stimulator
Sham
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Portable Neuromodulation Stimulator
n=25 participants at risk
All participants will receive balance, gait and breathing exercises. In addition to the exercises, the Portable Neuromodulation Stimulator active group members will receive perceivable electrical stimulation felt as a moderately intense tingling sensation. Each participant will be issued their own PoNS device.
|
Sham
n=21 participants at risk
All participants will receive balance, gait and breathing exercises. In addition to the exercises, the sham group will wear the mouthpiece and receive a non-perceivable stimulus. Each participant will be issued their own PoNS device.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Wound on foot
|
8.0%
2/25 • Adverse events were collected from enrollment until their final follow up assessment visit (Visit 18), up to 24 weeks
Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results or adverse events.
|
0.00%
0/21 • Adverse events were collected from enrollment until their final follow up assessment visit (Visit 18), up to 24 weeks
Seven participants were enrolled and assigned a study ID but were not included in the Outcome Measures analysis population. These participants did not receive study intervention (device never activated) due to screen failure or other reasons for discontinuation prior to randomization/treatment initiation. As they did not receive an allocated intervention, they are not included in the arm-level results or adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place