MedTrace Logo

Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy

NCT03256357 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-10-28

No results posted yet for this study

Summary

A randomized, controlled, and evaluator-blinded trail will be carried out comparing CIMT with or without AOT on sensorimotor outcome in children with unilateral CP aged 5 to 12 years. Additionally the potential role of neurological factors, including the anatomical characterization of the brain lesion, structural/functional connectivity and cortical reorganization, on treatment response will be investigated.

Conditions

  • Cerebral Palsy

Interventions

BEHAVIORAL

Constraint-induced movement therapy

In a 2-week day camp model children receive constraint- induced movement therapy for six hours a day, for 9 out of 11 consecutive days. All children wear a tailor made hand splint on the unaffected upper limb for 6 hours per day while performing unimanual exercises individually or in a group based on shaping and repetitive practice.

BEHAVIORAL

Action observation training

Action observation training consists of 15 sessions of 1 hour. Children watch 3 minute video clips of unimanual goal-directed actions followed by 3 minutes of execution of the actions.

BEHAVIORAL

Placebo observation training

Placebo observation training consists of 15 sessions of 1 hour. Children perform the same actions as the AOT training after watching computer games without biological movements.

Sponsors & Collaborators

  • ETH Zurich (Switzerland)

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • KU Leuven

    lead OTHER

Principal Investigators

  • Cristina Simon-Martinez · KU Leuven

  • Hilde Feys, Prof · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT03256357 on ClinicalTrials.gov