Sensory Stimulation During CIMT

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Cerebral Palsy

Treatments: Behavioral: Standardized Constraint-Induced Movement Therapy; Behavioral: Vibration; Behavioral: Placebo (for vibration)

Study type: Interventional

Funder types: Other

Identifiers

NCT03558230

PRO74164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

Vibration

Experimental group

Description:

The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.

Treatment:

Behavioral: Vibration

Behavioral: Standardized Constraint-Induced Movement Therapy

No Vibration

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Placebo (for vibration)

Behavioral: Standardized Constraint-Induced Movement Therapy