Cerebral PalsyNCT03256357
Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy
A study testing Constraint-induced movement therapy and Action observation training in people with Cerebral Palsy, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Constraint-induced movement therapy and Action observation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2014to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- upper limb surgery two years prior to enrollment
- botulinum toxin A injections six months prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Intensive Upper Limb Training Combining Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Constraint-induced movement therapy, Action observation training, Placebo observation training
- Keywords
- unilateral cerebral palsy, upper limb rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-induced movement therapyBehavioural
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 trainingBehavioural
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.
Placebo observation trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CIMT + AOT | Active comparator | 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. Receives: Behavioral: Constraint-induced movement therapy; Behavioral: Action observation training |
| CIMT + POT | Placebo comparator | 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. Receives: Behavioral: Constraint-induced movement therapy; Behavioral: Placebo observation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, pre and post intervention (within one week), 6 months follow-up
Secondary outcomes (13)
Change in Melbourne Assessment of Unilateral Upper Limb Function
The Melbourne Assessment evaluates quality of movement in 16 functional unimanual tasks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: pre intervention (within one week), 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 Jan 2014
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland), University of Pisa
- Responsible party
- Principal investigator, Klingels Katrijn, KU Leuven
- Investigators
- Cristina Simon-Martinez, Principal investigator, KU LeuvenHilde Feys, Prof, Study director, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256357
- Sponsor's protocol ID
- CIMT and AOT in unilateral CP
- Status last verified
- Oct 2019
- First submitted
- 14 Jul 2017
- Last updated
- 28 Oct 2019
- Results posted
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32031542Simon-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.
PubMed 30064396
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensive Upper Limb Training Combining Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03256357
- Acronym / sponsor ID
- CIMT and AOT in unilateral CP
- Conditions
- Cerebral Palsy
- Keywords
- unilateral cerebral palsy, upper limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland), University of Pisa
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT + AOT | Active comparator | Behavioral: Constraint-induced movement therapy, Behavioral: Action observation trainingIn 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. |
| CIMT + POT | Placebo comparator | Behavioral: Constraint-induced movement therapy, Behavioral: Placebo observation trainingIn 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- upper limb surgery two years prior to enrollment
- botulinum toxin A injections six months prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constraint-induced movement therapyIn 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. | Behavioural | CIMT + AOT, CIMT + POT |
| Action observation trainingAction 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. | Behavioural | CIMT + AOT |
| Placebo observation trainingPlacebo 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. | Behavioural | CIMT + POT |
Primary outcome
Change in Assisting Hand Assessment (AHA)
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
The AHA, a Rasch-based performance scale, measures how effectively the affected hand is spontaneously used during performance of bimanual tasks.
13 secondary outcomes
Change in Melbourne Assessment of Unilateral Upper Limb Function
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in Jebsen-Taylor Hand Function Test
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in Tyneside Pegboard test
Time frame: pre and post intervention (within one week), 6 months follow-up
Change in passive range of motion (PROM)
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in muscle tone
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in muscle strength
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in grip strength
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in muscle fatigability
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in Abilhand-Kids questionnaire
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: baseline, pre and post intervention (within one week), 6 months follow-up
Change in Upper limb Three-dimensional movement analysis (3DMA)
Time frame: pre and post intervention (within one week), 6 months follow-up
Change in Assessment of Life Habits for children (LIFE-H Kids)
Time frame: pre intervention (within one week), 6 months follow-up
Change in Cerebral Palsy Quality of Life Questionnaire (CP-QOL)
Time frame: pre intervention (within one week), 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Derived from this study: PubMed 32031542Simon-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.
- Derived from this study: PubMed 30064396Simon-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.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Simon-Martinez principal investigator
KU Leuven
Hilde Feys, Prof study director
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-induced movement therapy and Action observation training in people with Cerebral Palsy, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Assisting Hand Assessment (AHA) (time frame: baseline, pre and post intervention (within one week), 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.