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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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Background: Problems in upper limb (UL) function in children with unilateral cerebral palsy (UCP) are traditionally trained with motor execution treatment models, such as Constraint Induced Movement Therapy (CIMT). However new approaches based on a neurophysiological model such as action observation training (AOT) may provide new opportunities for enhanced motor learning.

Aim: The aim of study is to investigate the effects of an intensive treatment model consisting of CIMT and AOT compared to CIMT alone on UL function in children with UCP. 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 analysed.

Methods/Design: A randomized, controlled, evaluator-blinded trial (RCT) will be conducted in 40 children between 5 and 12 years of age. Before randomization, children are stratified according to their House Functional Classification Scale, age and type of cortical reorganization. The Intervention is accomplished during a 2-week day camp in which the children receive intensive therapy for six hours a day on 9 out of 11 consecutive days (54 h) including AOT or placebo observation training (POT) (15h). During the AOT the children in the experimental group watch video sequences showing goal-directed actions and subsequently execute the observed actions with the affected UL. Children in the POT group perform the same actions after watching computer games without biological movements.

Outcome assessments include qualitative and quantitative measures of UL sensorimotor function across the International Classification of Functioning, Disability and Health (ICF). The primary outcome measure is the Assisting Hand Assessment (AHA). The medical imaging protocol includes structural Magnetic Resonance Imaging (MRI), Diffusion Kurtosis Imaging (DKI), resting state functional MRI (rs-fMRI) and Transcranial magnetic stimulation (TMS). The timeline for the assessment is T0 (1-1.5 month before the camp onset), T1 (before the intervention), T2 (after the intervention) and T3 (6 months after the intervention). Linear mixed models will be used to study time effects of the interventions and the interaction with neurological variables as covariates.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CIMT + AOT

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.

Action observation training consists of 15 sessions of 1 hour. Children watch video sequences showing goal-directed actions and subsequently execute the observed actions with the affected upper limb.

Group Type ACTIVE_COMPARATOR

Constraint-induced movement therapy

Intervention Type BEHAVIORAL

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.

Action observation training

Intervention Type BEHAVIORAL

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.

CIMT + POT

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.

Placebo observation training consists of 15 sessions of 1 hour.This group performs the same actions after watching computer games without biological movements.

Group Type PLACEBO_COMPARATOR

Constraint-induced movement therapy

Intervention Type BEHAVIORAL

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.

Placebo observation training

Intervention Type BEHAVIORAL

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.

Interventions

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