Clinical trial NCT03256357: Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy
Official title: Effectiveness of Intensive Upper Limb Training Combining Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: unilateral cerebral palsy
upper limb rehabilitation
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: ETH Zurich (Switzerland)
name: University of Pisa
First posted: 2017-08-22
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Assisting Hand Assessment (AHA)
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
Secondary outcomes:
measure: Change in Melbourne Assessment of Unilateral Upper Limb Function
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in Jebsen-Taylor Hand Function Test
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in Tyneside Pegboard test
timeFrame: pre and post intervention (within one week), 6 months follow-up
measure: Change in passive range of motion (PROM)
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in muscle tone
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in muscle strength
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in grip strength
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in muscle fatigability
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in Abilhand-Kids questionnaire
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in Children's Hand-use Experience Questionnaire (CHEQ)
timeFrame: baseline, pre and post intervention (within one week), 6 months follow-up
measure: Change in Upper limb Three-dimensional movement analysis (3DMA)
timeFrame: pre and post intervention (within one week), 6 months follow-up
measure: Change in Assessment of Life Habits for children (LIFE-H Kids)
timeFrame: pre intervention (within one week), 6 months follow-up
measure: Change in Cerebral Palsy Quality of Life Questionnaire (CP-QOL)
timeFrame: pre intervention (within one week), 6 months follow-up
Other outcomes:
measure: Structural Magnetic Resonance Imaging (MRI)
timeFrame: baseline
measure: Resting state functional Magnetic Resonance Imaging (rsfMRI)
timeFrame: baseline
measure: Diffusion weighted imaging
timeFrame: baseline
measure: Transcranial Magnetic Stimulation (TMS)
timeFrame: baseline
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: KU Leuven
name: Cristina Simon-Martinez
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Hilde Feys, Prof
role: STUDY_DIRECTOR
References:
citation: Simon-Martinez C, Mailleux L, Hoskens J, Ortibus E, Jaspers E, Wenderoth N, Sgandurra G, Cioni G, Molenaers G, Klingels K, Feys H. Randomized controlled trial combining constraint-induced movement therapy and action-observation training in unilateral cerebral palsy: clinical effects and influencing factors of treatment response. Ther Adv Neurol Disord. 2020 Jan 6;13:1756286419898065. doi: 10.1177/1756286419898065. eCollection 2020.
citation: Simon-Martinez C, Mailleux L, Ortibus E, Fehrenbach A, Sgandurra G, Cioni G, Desloovere K, Wenderoth N, Demaerel P, Sunaert S, Molenaers G, Feys H, Klingels K. Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial. BMC Pediatr. 2018 Jul 31;18(1):250. doi: 10.1186/s12887-018-1228-2.