Sensory Stimulation During Constraint-Induced Movement Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Feasibility (Total Number of Hours That Participants Wear the Device)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
A double-blinded stratified randomized controlled trial
Eligibility Criteria
- Ages
- 3 Years to 9 Years (Child)
- Sex
- All
- Accepts 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Vibration
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Intervention: Standardized Constraint-Induced Movement Therapy (Behavioral)
Vibration
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Intervention: Vibration (Behavioral)
No Vibration
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
- The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
Intervention: Standardized Constraint-Induced Movement Therapy (Behavioral)
No Vibration
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
- The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
Intervention: Placebo (for vibration) (Behavioral)
Outcomes
Primary Outcomes
Feasibility (Total Number of Hours That Participants Wear the Device)
Time Frame: through 5-day study completion.
total number of hours that participants wear the device
Secondary Outcomes
No secondary outcomes reported