Trial Outcomes & Findings for Fully Remote Use of IpsiHand Device in Hemiparetic Stroke (NCT NCT05965713)
NCT ID: NCT05965713
Last Updated: 2026-08-12
Results Overview
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
12 weeks
Results posted on
2026-08-12
Participant Flow
Participant milestones
| Measure |
Home Based BCI Rehabilitation (BCI)
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.
|
Home Exercise Rehabilitation Regimen Program (HEP)
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
37
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
17
|
Reasons for withdrawal
| Measure |
Home Based BCI Rehabilitation (BCI)
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.
|
Home Exercise Rehabilitation Regimen Program (HEP)
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
17
|
Baseline Characteristics
Subjects with Protocol Deviations after randomization were excluded from analysis
Baseline characteristics by cohort
| Measure |
Home Based BCI Rehabilitation (BCI)
n=37 Participants
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.
|
Home Exercise Rehabilitation Regimen Program (HEP)
n=25 Participants
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
58.1 Years
STANDARD_DEVIATION 15.7 • n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
53.1 Years
STANDARD_DEVIATION 16.6 • n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
56.4 Years
STANDARD_DEVIATION 16.2 • n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Sex: Female, Male
Female
|
13 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
11 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
24 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Sex: Female, Male
Male
|
24 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
14 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
38 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
21 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
49 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
2 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
6 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
1 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
2 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Race/Ethnicity, Customized
Other/Unknown
|
4 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
1 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
5 Participants
n=1 Participants • Subjects with Protocol Deviations after randomization were excluded from analysis
|
|
Upper Extremity Fugl-Meyer
|
26.3 Units on a scale
STANDARD_DEVIATION 17.9 • n=1 Participants • Participants with protocol deviations or with missing data after enrollment were excluded from evaluation
|
26.7 Units on a scale
STANDARD_DEVIATION 14.4 • n=1 Participants • Participants with protocol deviations or with missing data after enrollment were excluded from evaluation
|
26.5 Units on a scale
STANDARD_DEVIATION 16.4 • n=1 Participants • Participants with protocol deviations or with missing data after enrollment were excluded from evaluation
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Noted Protocol Deviations and missing Completion timepoints excluded subjects from per protocol analysis
Assessment tool of upper extremity motor function. Lowest score 0, highest score 66.
Outcome measures
| Measure |
Home Based BCI Rehabilitation (BCI)
n=31 Participants
Participants were instructed to use the device for home-based therapy sessions 1 hour per day, 5 days per week, for a continuous 12 weeks.
|
Home Exercise Rehabilitation Regimen Program (HEP)
n=21 Participants
The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.
|
|---|---|---|
|
Upper Extremity Fugl-Meyer (UEFM)
|
32.6 Units on a scale
Standard Deviation 18.3
|
28.1 Units on a scale
Standard Deviation 16.6
|
Adverse Events
Home Exercise Rehabilitation Regimen Program (HEP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Based BCI Rehabilitation (BCI)
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
Seth Wilk, PhD, Chief Innovation Officer
Neurolutions, Inc.
Phone: 1 833 438 4774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place