Trial Outcomes & Findings for Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke (NCT NCT04569123)
NCT ID: NCT04569123
Last Updated: 2026-02-09
Results Overview
The Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks. Range: 0 seconds to \>120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2026-02-09
Participant Flow
Participant milestones
| Measure |
Vibration
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Baseline characteristics by cohort
| Measure |
Vibration
n=30 Participants
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
n=31 Participants
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 year
STANDARD_DEVIATION 13 • n=41 Participants
|
59 year
STANDARD_DEVIATION 10 • n=1581 Participants
|
60 year
STANDARD_DEVIATION 11 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=41 Participants
|
14 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=41 Participants
|
17 Participants
n=1581 Participants
|
39 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=41 Participants
|
20 Participants
n=1581 Participants
|
30 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
29 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksThe Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks. Range: 0 seconds to \>120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.
Outcome measures
| Measure |
Vibration
n=25 Participants
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
n=22 Participants
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
|---|---|---|
|
Change in Wolf Motor Function Test (WMFT) Movement Time
|
-4 Seconds (sec)
Standard Deviation 6
|
-9 Seconds (sec)
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksThe Box and Blocks Test (BBT) measures unilateral gross manual dexterity. Participants move as many blocks as possible from one side of a box to the other in 60 seconds. Range: 0-150 blocks (typical). Interpretation: Higher scores indicate better manual dexterity.
Outcome measures
| Measure |
Vibration
n=25 Participants
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
n=22 Participants
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
|---|---|---|
|
Change in Box and Blocks Test (BBT) Score
|
2 Number of blocks moved
Standard Deviation 4
|
4 Number of blocks moved
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksThe Action Research Arm Test (ARAT) is a standardized measure of upper limb functional ability. It contains 19 items scored 0-3, summed to a total score. Range: 0-57. Interpretation: Higher scores indicate better upper limb function.
Outcome measures
| Measure |
Vibration
n=25 Participants
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
n=22 Participants
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
|---|---|---|
|
Change in Action Research Arm Test (ARAT) Score
|
3 Score on a scale
Standard Deviation 3
|
4 Score on a scale
Standard Deviation 5
|
Adverse Events
Vibration
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
No Vibration
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vibration
n=30 participants at risk
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
n=31 participants at risk
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
|---|---|---|
|
General disorders
serious adverse event
|
10.0%
3/30 • From enrollment through completion of study participation, up to 2.5 months.
|
6.5%
2/31 • From enrollment through completion of study participation, up to 2.5 months.
|
Other adverse events
| Measure |
Vibration
n=30 participants at risk
The device will deliver imperceptible vibration for the treatment group.
real stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
No Vibration
n=31 participants at risk
The device will deliver no vibration for the control group.
No stimulation: Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
|---|---|---|
|
General disorders
other adverse event
|
83.3%
25/30 • From enrollment through completion of study participation, up to 2.5 months.
|
74.2%
23/31 • From enrollment through completion of study participation, up to 2.5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place