N/A
N=13
Sensory Stimulation During CIMT
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT03558230 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Feasibility (Total Number of Hours That Participants Wear the Device) — 28.3; 27.9 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standardized Constraint-Induced Movement Therapy (Behavioral); Vibration (Behavioral); Placebo (for vibration) (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility (Total Number of Hours That Participants Wear the Device) |
28.3; 27.9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03558230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.