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

Study Overview
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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.

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.

Official Title
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Effectiveness of Intensive Upper Limb Training Combining Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: Constraint-induced movement therapy
* Behavioral: Action observation training
* Behavioral: Placebo observation training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of unilateral CP aged 5-12 years sufficient cooperation to comprehend and complete the test procedure minimal ability to actively grasp and stabilize an object Exclusion Criteria: upper limb surgery two years prior to enrollment botulinum toxin A injections six months prior to enrollment

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CIMT + AOT<br>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. | Behavioral: Constraint-induced movement therapy<br>* 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.<br>Behavioral: Action observation training<br>* 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.<br>|
| Placebo Comparator: CIMT + POT<br>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. | Behavioral: Constraint-induced movement therapy<br>* 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.<br>Behavioral: Placebo observation training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Assisting Hand Assessment (AHA) | The AHA, a Rasch-based performance scale, measures how effectively the affected hand is spontaneously used during performance of bimanual tasks. | baseline, pre and post intervention (within one week), 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Melbourne Assessment of Unilateral Upper Limb Function | The Melbourne Assessment evaluates quality of movement in 16 functional unimanual tasks. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in Jebsen-Taylor Hand Function Test | The Jebsen-Taylor hand function test measures manual dexterity in six unimanual tasks, by means of movement time expressed in seconds for both hands. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in Tyneside Pegboard test | The Tyneside pegboard test is an adapted 9-hole pegboard test and assesses unimanual and bimanual dexterity. | pre and post intervention (within one week), 6 months follow-up | 
| Change in passive range of motion (PROM) | PROM of shoulder flexion, abduction, external and internal rotation, elbow extension, forearm supination and wrist extension is measured using a universal goniometer. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in muscle tone | Muscle tone is evaluated in 11 muscle groups using the Modified Ashworth Scale (MAS), ranging from 0 to 4. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in muscle strength | Muscle strength is evaluated in nine muscle groups using manual muscle testing (MMT), ranging from 0 to 5. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in grip strength | Grip strength is assessed with a Jamar dynamometer®. The average of three consecutive maximum contractions is recorded for both hands. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in muscle fatigability | Muscle fatigability during an isometric grip strength task is assessed based on a 30 second sustained contraction with E-link software. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in Abilhand-Kids questionnaire | The Abilhand- Kids questionnaire is a Rasch-based inventory of 21 mostly bimanual activities that the parents are asked to judge as: 0 (impossible), 1 (difficult), and 2 (easy), irrespective of the limb(s) actually used to do the activity. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in Children's Hand-use Experience Questionnaire (CHEQ) | CHEQ is a questionnaire to evaluate the experience of children and adolescents in using the affected hand in activities where usually two hands are needed. | baseline, pre and post intervention (within one week), 6 months follow-up | 
| Change in Upper limb Three-dimensional movement analysis (3DMA) | This quantitative assessment comprises upper limb kinematics during functionally relevant aiming and grasping tasks. | pre and post intervention (within one week), 6 months follow-up | 
| Change in Assessment of Life Habits for children (LIFE-H Kids) | LIFE-H Kids assesses the quality of social participation of children with disabilities by estimating how a client accomplishes activities of daily living and social roles | pre intervention (within one week), 6 months follow-up | 
| Change in Cerebral Palsy Quality of Life Questionnaire (CP-QOL) | CP-QOL is a parent report that assesses the wellbeing across various domains of life in children with cerebral palsy. | pre intervention (within one week), 6 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unilateral cerebral palsy, upper limb rehabilitation