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Early Childhood Constraint Therapy in Cerebral Palsy

NCT02567630 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2020-02-18

No results posted yet for this study

Summary

This is a prospective interventional study involving young children who will all receive non-invasive, passive assessments of sensory and motor function. In addition a subpopulation of young children with cerebral palsy will participate in a randomized controlled trial of constraint-induced movement therapy, a routinely prescribed therapy used in clinical practice for children with motor difficulties. The study attempts to apply a rigorous scientific approach to study a widely used but poorly studied practice. The design is an RCT with wait-list controls to allow all children to benefit from the therapy, even if they are randomized to the control group. All children, regardless of group allocation will continue with their standard of care occupational and physical therapy throughout the study.

Conditions

  • Cerebral Palsy

Interventions

BEHAVIORAL

Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy

The CIMT intervention includes 3 components: (1) placement of a removable soft constraint for ½ each day, with a non-invasive wear monitor (2) demonstration and prescribed home-use of a sensory kit (3) and a reach/grasp tool. The intervention lasts 4 weeks as has been published in older children as well as used in infant trial descriptions.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Nathalie L Maitre, MD, PhD · Nationwide Childrens hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-05
Primary Completion
2020-01-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02567630 on ClinicalTrials.gov