Trial Outcomes & Findings for Sensory Stimulation During CIMT (NCT NCT03558230)
NCT ID: NCT03558230
Last Updated: 2019-03-08
Results Overview
total number of hours that participants wear the device
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
through 5-day study completion.
Results posted on
2019-03-08
Participant Flow
Participant milestones
| Measure |
Vibration
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Vibration: Vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
No Vibration
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Placebo (for vibration): No vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensory Stimulation During CIMT
Baseline characteristics by cohort
| Measure |
Vibration
n=7 Participants
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Vibration: Vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
No Vibration
n=6 Participants
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Placebo (for vibration): No vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.7 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.5 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
PRIMARY outcome
Timeframe: through 5-day study completion.total number of hours that participants wear the device
Outcome measures
| Measure |
Vibration
n=7 Participants
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Vibration: Vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
No Vibration
n=6 Participants
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Placebo (for vibration): No vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
|---|---|---|
|
Feasibility (Total Number of Hours That Participants Wear the Device)
|
28.3 Hours
Standard Deviation 0.3
|
27.9 Hours
Standard Deviation 1
|
Adverse Events
Vibration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Vibration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vibration
n=7 participants at risk
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Vibration: Vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
No Vibration
n=6 participants at risk
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
Standardized Constraint-Induced Movement Therapy: The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Placebo (for vibration): No vibration applied to the wrist.
The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Temporary skin redness
|
28.6%
2/7 • Number of events 2 • Throughout the 5-day study period
|
16.7%
1/6 • Number of events 1 • Throughout the 5-day study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place