Cerebral Palsy
Conditions
Keywords
pediatric, hemiplegic, hand function
Brief summary
The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.
Detailed description
The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.
Interventions
BEHAVIORALStandardized 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.
BEHAVIORALVibration
Vibration applied to the wrist.
BEHAVIORALPlacebo (for vibration)
No vibration applied to the wrist.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A double-blinded stratified randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 3 and 9 * Have unilateral upper limb motor weakness. * Use the affected extremity as a gross assist during play and self-care activities. * No significant developmental delays that would limit spontaneous use of the more affected extremity. * Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity. * No other health impairment other than hemiparesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Total Number of Hours That Participants Wear the Device) | through 5-day study completion. | total number of hours that participants wear the device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | No Vibration | Total | Vibration |
|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 1.9 | 5.6 years STANDARD_DEVIATION 1.8 | 5.7 years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 2 / 7 | 1 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Feasibility (Total Number of Hours That Participants Wear the Device)
total number of hours that participants wear the device
Time frame: through 5-day study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vibration | Feasibility (Total Number of Hours That Participants Wear the Device) | 28.3 Hours | Standard Deviation 0.3 |
| No Vibration | Feasibility (Total Number of Hours That Participants Wear the Device) | 27.9 Hours | Standard Deviation 1 |