Early Childhood Constraint Therapy in Cerebral Palsy

Status unconfirmed · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT02567630

Run by

Nationwide Children's Hospital

People needed

145

Starts

2015-10-05

Expected to finish

2020-12-31

Last updated by the study team

2020-02-18

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• CP children (n=72): Inclusion criteria will be diagnosis of hemiparetic or asymmetric CP as determined by published algorithms and neurologic exam.
• TD children (n=144): Inclusion criteria will be GA and sex-matched compared to the CP group, with CA at assessment matched to the CP group at baseline (72 children) and at the 7-month assessment (72 children). Exclusion criteria will be any motor or sensory impairment as defined by neurologic exam and/or scaled motor scores below 8 for CA on the Bayley III and cognitive impairment or delays as described for the CP group.

You may not qualify if…

• CP children: exclusion criteria will be CP with Gross Motor Function Classification Score (GMFCS) of 4-5, corresponding to poor or absent mobility and neck control; receipt of Botox to the affected extremity within 3 months of study entry; or scores of <70 on the Bayley Scales of Infant Development (Bayley III) cognitive composite.
• TD children: Exclusion criteria will be any motor or sensory impairment as defined by neurologic exam and/or scaled motor scores below 8 for CA on the Bayley III and cognitive impairment or delays as described for the CP group.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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