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

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

Sponsors

Lead sponsor: KU Leuven

Collaborator: ETH Zurich (Switzerland)
University of Pisa, Italy

Source KU Leuven
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.

Overall Status Completed
Start Date January 1, 2014
Completion Date February 28, 2018
Primary Completion Date February 28, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Assisting Hand Assessment (AHA) baseline, pre and post intervention (within one week), 6 months follow-up
Secondary Outcome
Measure Time Frame
Change in Melbourne Assessment of Unilateral Upper Limb Function baseline, pre and post intervention (within one week), 6 months follow-up
Change in Jebsen-Taylor Hand Function Test baseline, pre and post intervention (within one week), 6 months follow-up
Change in Tyneside Pegboard test pre and post intervention (within one week), 6 months follow-up
Change in passive range of motion (PROM) baseline, pre and post intervention (within one week), 6 months follow-up
Change in muscle tone baseline, pre and post intervention (within one week), 6 months follow-up
Change in muscle strength baseline, pre and post intervention (within one week), 6 months follow-up
Change in grip strength baseline, pre and post intervention (within one week), 6 months follow-up
Change in muscle fatigability baseline, pre and post intervention (within one week), 6 months follow-up
Change in Abilhand-Kids questionnaire baseline, pre and post intervention (within one week), 6 months follow-up
Change in Children's Hand-use Experience Questionnaire (CHEQ) baseline, pre and post intervention (within one week), 6 months follow-up
Change in Upper limb Three-dimensional movement analysis (3DMA) pre and post intervention (within one week), 6 months follow-up
Change in Assessment of Life Habits for children (LIFE-H Kids) pre intervention (within one week), 6 months follow-up
Change in Cerebral Palsy Quality of Life Questionnaire (CP-QOL) pre intervention (within one week), 6 months follow-up
Enrollment 44
Condition
Intervention

Intervention type: Behavioral

Intervention name: Constraint-induced movement therapy

Description: 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.

Intervention type: Behavioral

Intervention name: Action observation training

Description: 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.

Arm group label: CIMT + AOT

Intervention type: Behavioral

Intervention name: Placebo observation training

Description: 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.

Arm group label: CIMT + POT

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

Gender: All

Minimum age: 5 Years

Maximum age: 12 Years

Healthy volunteers: No

Overall Official
Location
facility
KU Leuven
Location Countries

Belgium

Verification Date

October 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: KU Leuven

Investigator full name: Klingels Katrijn

Investigator title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CIMT + AOT

Arm group type: Active Comparator

Description: 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.

Arm group label: CIMT + POT

Arm group type: Placebo Comparator

Description: 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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov