Trials / Completed
CompletedNCT03558230
Sensory Stimulation During CIMT
Sensory Stimulation During Constraint-Induced Movement Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Medical University of South Carolina · Academic / Other
- Sex
- All
- Age
- 3 Years – 9 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | Vibration | Vibration applied to the wrist. |
| BEHAVIORAL | Placebo (for vibration) | No vibration applied to the wrist. |
Timeline
- Start date
- 2018-07-16
- Primary completion
- 2018-10-28
- Completion
- 2018-10-28
- First posted
- 2018-06-15
- Last updated
- 2019-03-08
- Results posted
- 2019-03-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03558230. Inclusion in this directory is not an endorsement.