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Completed

NCT Number: NCT03558230

Sensory Stimulation During CIMT

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Standardized Constraint-Induced Movement Therapy

Behavioral

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

Behavioral

Vibration applied to the wrist.

Placebo (for vibration)

Behavioral

No vibration applied to the wrist.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Sensory Stimulation During Constraint-Induced Movement Therapy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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