Trial Outcomes & Findings for Sensory Stimulation to Enhance Hand Function Post Stroke (NCT NCT02675764)
NCT ID: NCT02675764
Last Updated: 2024-03-27
Results Overview
Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
Experimental (Therapy + Stimulation)
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program
|
Placebo (Therapy + Stimulation Placebo)
The control group wears the vibration device with no vibration during therapy.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensory Stimulation to Enhance Hand Function Post Stroke
Baseline characteristics by cohort
| Measure |
Experimental
n=6 Participants
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program
|
Placebo
n=6 Participants
The control group will wear the vibration device with no vibration.
* Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level.
* The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 10 • n=5 Participants
|
64 years
STANDARD_DEVIATION 8 • n=7 Participants
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
baseline hand motor function (Box and Block Test score)
|
29 blocks
STANDARD_DEVIATION 15 • n=5 Participants
|
28 blocks
STANDARD_DEVIATION 11 • n=7 Participants
|
29 blocks
STANDARD_DEVIATION 12 • n=5 Participants
|
PRIMARY outcome
Timeframe: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Outcome measures
| Measure |
Experimental (Therapy + Stimulation)
n=6 Participants
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program
|
Placebo (Therapy + Stimulation Placebo)
n=6 Participants
The control group wears the vibration device with no vibration.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program
|
|---|---|---|
|
Box and Block Test (BBT) About a Week After the 2-week Intervention
|
6 change in # of blocks
Standard Error .8
|
-2 change in # of blocks
Standard Error .7
|
PRIMARY outcome
Timeframe: follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Outcome measures
| Measure |
Experimental (Therapy + Stimulation)
n=6 Participants
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program
|
Placebo (Therapy + Stimulation Placebo)
n=6 Participants
The control group wears the vibration device with no vibration.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program
|
|---|---|---|
|
Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention
|
4 change in # of blocks
Standard Error .8
|
0.5 change in # of blocks
Standard Error .8
|
PRIMARY outcome
Timeframe: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
Outcome measures
| Measure |
Experimental (Therapy + Stimulation)
n=6 Participants
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program
|
Placebo (Therapy + Stimulation Placebo)
n=6 Participants
The control group wears the vibration device with no vibration.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program
|
|---|---|---|
|
WMFT About a Week After the 2-week Intervention
|
-0.19 change in ln(sec)
Standard Error 0.07
|
0.00 change in ln(sec)
Standard Error 0.07
|
PRIMARY outcome
Timeframe: follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.
Outcome measures
| Measure |
Experimental (Therapy + Stimulation)
n=6 Participants
The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
Vibration: peripheral vibration at the wrist skin at an imperceptible level
therapy: standardized hand therapy program
|
Placebo (Therapy + Stimulation Placebo)
n=6 Participants
The control group wears the vibration device with no vibration.
Placebo (for vibration): No peripheral vibration at the wrist skin
therapy: standardized hand therapy program
|
|---|---|---|
|
WMFT at Least 2 Weeks After the 2-week Intervention
|
-0.090 change in ln(sec)
Standard Error 0.074
|
-0.089 change in ln(sec)
Standard Error 0.074
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place