Cerebral PalsyNCT06593158
Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam
A study testing Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. and Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts. in people with Cerebral Palsy, run by Université Catholique de Louvain.
Trial summary
This study will use a randomized controlled trial design with a longitudinal baseline to assess the effectiveness of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on motor function and the ability to perform daily activities in Vietnamese children with cerebral palsy, specifically through… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. and Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis: Cerebral palsy
- Type of Cerebral palsy: Bilateral cerebral palsy
- Level of gross motor function: level II to IV of GMFCS E\& R
- Level of manual ability: level I to IV of mini- MACS
- Environmental factors: Having caregiver support during the study (availability of a caregiver for 5h per day during two weeks of therapy)
- Age of children: 2 to 6 years old
Who cannot join
- The child has uncontrolled seizures.
- The child has visual impairment that could interfere with the assessment and treatment.
- The child has severe cognitive problems, unable to understand or be interested in simple games
- Other intensive therapy or surgery/medical intervention that could interfere with study results in the past 6 months and during the study period (e.g. botulinum toxin, etc).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Parent-delivered Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Young Children With Cerebral Palsy in Vietnam
This study will use a randomized controlled trial design with a longitudinal baseline to assess the effectiveness of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on motor function and the ability to perform daily activities in Vietnamese children with cerebral palsy, specifically through a caregiver-delivered approach. Participants will be randomly assigned to one of two groups: HABIT-ILE at Camp with Caregivers and HABIT-ILE at Home with Caregivers. The study aims to determine whether a caregiver-delivered intervention will be effective compared to the "no intensive" phase and whether on-site intervention with the constant presence of supervisors may have additional effects.
Read the detailed description
Cerebral palsy (CP) is a group of non-progressive early onset neuromotor disorders that affect the developing brain of the fetus or infant. Motor disorders in CP are often accompanied by sensory, perceptual, cognitive, communicative, and behavioural disorders, and secondary musculoskeletal problems. CP is characterized by impairment in gross motor function involving large muscles which perform daily activities such as walking, standing, running, jumping and fine motor function involving small muscles in the hand and wrist which perform flexible hand and finger grip activities, communication ability. The purpose of rehabilitation in children with CP is to minimize the impact of physical disability, to improve independence in the community and to improve the quality of life of children and their families.
Traditionally, CP was managed through neurorehabilitation based on neurodevelopmental methods. However, the effectiveness of these methods is still being hotly debated. In contrast, there is evidence that intensive therapy based on motor skill learning is more effective in creating functional and neuroplastic changes. Intensive therapy is a high-intensity program completed daily for several weeks, focusing on repetitive tasks with gradually increasing difficulty towards functional goals identified by the child and the child's caregiver. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) has shown improvement in motor and functional outcomes in children with CP. HABIT-ILE therapy is recommended in high-income countries (HIC) in the form of camps where children practice continuously for a short period (2 weeks), totalling 50-90 hours in a treatment session with therapists. In Vietnam, rehabilitation is not widely accessible, possibly due to high treatment costs and a lack of treatment facilities and staff. Recognizing the potential of HABIT-ILE therapy and the practical context of Vietnam, in this study, we aim to apply Parent-delivered HABIT-ILE and explore the effectiveness of this therapy on children with CP in Vietnam.
- Conditions
- Cerebral Palsy
- Being tested
- Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts., Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts.
- Keywords
- HABIT-ILE, Cerebral Palsy, Caregiver -delivered, Intensive therapy, Home 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.
Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts.Behavioural
- The caregivers delivering HABIT-ILE therapy at camp will follow the same principles as the usual HABIT-ILE. The therapy will take place in a rehabilitation center, and caregivers will provide therapy during the sessions, coached by trained supervisors on site
- The intervention day will then take place, lasting for 5 hours with the constant presence of supervisors. This will be divided into two sessions: a 3-hour intervention in the morning followed by a lunch break, and a 2-hour intervention in the afternoon.
Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts.Behavioural
- The caregivers delivering HABIT-ILE therapy at home will follow the same principles as the usual HABIT-ILE. The therapy will take place at children's home, caregivers will provide therapy during the sessions, coached by trained supervisors online
- The intervention day will then take place, lasting for 5 hours with the supervisors through online setting. This will be divided into two sessions: a 3-hour intervention in the morning followed by a lunch break, and a 2-hour intervention in the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE at Camp with Caregivers | Active comparator | Not described Receives: Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. |
| HABIT-ILE at Home with Caregivers | Active comparator | Not described Receives: Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure -66 (GMFM- 66)
The GMFM-66 is a 66-item scale that is divided into five aspects of gross motor function: lying and rolling, sitting, crawling, and kneeling, standing, and walking, running, and jumping. All items are arranged in order of difficulty and have a common unit of change from 0 to 100
Measured: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Melbourne Assessment 2
- The Melbourne Assessment 2 (MA2) is a reliable and valid tool used to assess upper limb movement quality in children aged 2.5 to 15 with neurological impairments. It evaluates four key areas: range of motion, accuracy of reaching and placement, dexterity of grasp, release, and manipulation, and fluency of movement. The 14-item test involves children reaching for, grasping, releasing, and manipulating simple objects while their performance is video recorded for later scoring.
Measured: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Secondary outcomes (4)
ACTIVLIM-CP-WA questionnaire
ACTIVLIM-CP-WA questionnaire measures global performance of daily life activities in children with cerebral palsy (CP). The ACTIVLIM-CP-WA was built on the parents' perception and involves 31 items covering the domain of self-care, mobility and domestic life of the International Classification of Functioning, Disability and Health, Child, and Youth version (ICF-CY). The 31 items of the ACTIVLIM-CP-WA include 21 items for preschoolers (2 to 6 years), 23 items for children aging 6 to 12 years and 19 items for teens (12 to 19 years). Parents are instructed to estimate their child's difficulty in performing the activities related to the age of the child, as mentioned in the questionnaire, on three-level responses: Impossible (the child is unable to perform the activity alone), Difficult (the child is able to perform the activity alone, but experiences some difficulties), Easy (the child is able to perform the activity alone, without any difficulty).
Measured: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Paediatric Evaluation of Disability Inventory (PEDI)
PEDI is an interview-based tool that assesses functional performance in children. It is divided into three parts. In part I, this tool assesses in Functional kills of children with some domains such as: Self Care, Mobility, Social Function. Each domain evaluates specific tasks including feeding, dressing, walking, and communicating with others. It is scored on a four-point scale: 0 - unable, 1 - capable. In part II and III, this tool assesses in Caregiver Assistance with some domain such as: Self-Care, Mobility, Social Function. Using a 5-point scale: 5 - independence, 4 - supervision, 3 - average assistance, 2 - minimal assistance, 1 - maximum assistance, 0 - complete assistance.
Measured: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
The Canadian Occupational Performance Measure (COPM)
COPM is a client-centred outcome measure that allows individuals to identify and prioritize daily issues that limit their participation in everyday life. The measure focuses on the performance of activities in all areas of life, including self-care, leisure, and productivity to identify and prioritize daily issues that limit their participation in everyday life. 5 of the most important goals are then further assessed using a 10-point scale for performance and satisfaction.
Measured: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
WHOQOL-BREF
WHOQOL-BREF is a self-administered questionnaire that includes 26 questions about individuals' perceptions of their health and mental state in the two weeks prior. Answers to the questions are scored on a 1-5 Likert scale, where 1 represents "disagree" or "strongly disagree" and 5 represents "strongly agree" or "extremely agree". WHOQOL-BREF consists of four domains, each with specific aspects: physical health, psychological, social relationships, environment.
Measured: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Model description
- The trial will be a single-blind, randomized controlled trial. Participants will be randomly assigned to one of two groups: HABIT-ILE Camp with Caregivers or HABIT-ILE at Home with Caregivers. Both groups will have longitudinal assessments two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593158
- Sponsor's protocol ID
- Parent-delivered HABIT-ILE
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen MND, Le HTN, Nguyen TV, Do TP, Saussez G, Bleyenheuft Y. Parent-delivered Hand-arm Bimanual Intensive Training Including Lower Extremity for young children with bilateral cerebral palsy in Vietnam: protocol for a randomised controlled trial. BMJ Open. 2026 Jul 29;16(7):e113596. doi: 10.1136/bmjopen-2025-113596.
PubMed 42526925
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parent-delivered Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Young Children With Cerebral Palsy in Vietnam
- ClinicalTrials.gov ID
- NCT06593158
- Acronym / sponsor ID
- Parent-delivered HABIT-ILE
- Conditions
- Cerebral Palsy
- Keywords
- HABIT-ILE, Cerebral Palsy, Caregiver -delivered, Intensive therapy, Home rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy at Ho Chi Minh City
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
This study will use a randomized controlled trial design with a longitudinal baseline to assess the effectiveness of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on motor function and the ability to perform daily activities in Vietnamese children with cerebral palsy, specifically through a caregiver-delivered approach. Participants will be randomly assigned to one of two groups: HABIT-ILE at Camp with Caregivers and HABIT-ILE at Home with Caregivers. The study aims to determine whether a caregiver-delivered intervention will be effective compared to the "no intensive" phase and whether on-site intervention with the constant presence of supervisors may have additional effects.
Detailed description
Cerebral palsy (CP) is a group of non-progressive early onset neuromotor disorders that affect the developing brain of the fetus or infant. Motor disorders in CP are often accompanied by sensory, perceptual, cognitive, communicative, and behavioural disorders, and secondary musculoskeletal problems. CP is characterized by impairment in gross motor function involving large muscles which perform daily activities such as walking, standing, running, jumping and fine motor function involving small muscles in the hand and wrist which perform flexible hand and finger grip activities, communication ability. The purpose of rehabilitation in children with CP is to minimize the impact of physical disability, to improve independence in the community and to improve the quality of life of children and their families.
Traditionally, CP was managed through neurorehabilitation based on neurodevelopmental methods. However, the effectiveness of these methods is still being hotly debated. In contrast, there is evidence that intensive therapy based on motor skill learning is more effective in creating functional and neuroplastic changes. Intensive therapy is a high-intensity program completed daily for several weeks, focusing on repetitive tasks with gradually increasing difficulty towards functional goals identified by the child and the child's caregiver. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) has shown improvement in motor and functional outcomes in children with CP. HABIT-ILE therapy is recommended in high-income countries (HIC) in the form of camps where children practice continuously for a short period (2 weeks), totalling 50-90 hours in a treatment session with therapists. In Vietnam, rehabilitation is not widely accessible, possibly due to high treatment costs and a lack of treatment facilities and staff. Recognizing the potential of HABIT-ILE therapy and the practical context of Vietnam, in this study, we aim to apply Parent-delivered HABIT-ILE and explore the effectiveness of this therapy on children with CP in Vietnam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will be a single-blind, randomized controlled trial. Participants will be randomly assigned to one of two groups: HABIT-ILE Camp with Caregivers or HABIT-ILE at Home with Caregivers. Both groups will have longitudinal assessments two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline.
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE at Camp with Caregivers | Active comparator | Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. |
| HABIT-ILE at Home with Caregivers | Active comparator | Behavioral: Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis: Cerebral palsy
- Type of Cerebral palsy: Bilateral cerebral palsy
- Level of gross motor function: level II to IV of GMFCS E\& R
- Level of manual ability: level I to IV of mini- MACS
- Environmental factors: Having caregiver support during the study (availability of a caregiver for 5h per day during two weeks of therapy)
Key exclusion criteria (4 listed)
- The child has uncontrolled seizures.
- The child has visual impairment that could interfere with the assessment and treatment.
- The child has severe cognitive problems, unable to understand or be interested in simple games
- Other intensive therapy or surgery/medical intervention that could interfere with study results in the past 6 months and during the study period (e.g. botulinum toxin, etc).
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 |
|---|---|---|
| Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts.* The caregivers delivering HABIT-ILE therapy at camp will follow the same principles as the usual HABIT-ILE. The therapy will take place in a rehabilitation center, and caregivers will provide therapy during the sessions, coached by trained supervisors on site * The intervention day will then take place, lasting for 5 hours with the constant presence of supervisors. This will be divided into two sessions: a 3-hour intervention in the morning followed by a lunch break, and a 2-hour intervention in the afternoon. | Behavioural | HABIT-ILE at Camp with Caregivers |
| Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts.* The caregivers delivering HABIT-ILE therapy at home will follow the same principles as the usual HABIT-ILE. The therapy will take place at children's home, caregivers will provide therapy during the sessions, coached by trained supervisors online * The intervention day will then take place, lasting for 5 hours with the supervisors through online setting. This will be divided into two sessions: a 3-hour intervention in the morning followed by a lunch break, and a 2-hour intervention in the afternoon. | Behavioural | HABIT-ILE at Home with Caregivers |
Primary outcome
Gross Motor Function Measure -66 (GMFM- 66)
Time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
The GMFM-66 is a 66-item scale that is divided into five aspects of gross motor function: lying and rolling, sitting, crawling, and kneeling, standing, and walking, running, and jumping. All items are arranged in order of difficulty and have a common unit of change from 0 to 100
Melbourne Assessment 2
Time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
- The Melbourne Assessment 2 (MA2) is a reliable and valid tool used to assess upper limb movement quality in children aged 2.5 to 15 with neurological impairments. It evaluates four key areas: range of motion, accuracy of reaching and placement, dexterity of grasp, release, and manipulation, and fluency of movement. The 14-item test involves children reaching for, grasping, releasing, and manipulating simple objects while their performance is video recorded for later scoring.
4 secondary outcomes
ACTIVLIM-CP-WA questionnaire
Time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Paediatric Evaluation of Disability Inventory (PEDI)
Time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
The Canadian Occupational Performance Measure (COPM)
Time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
WHOQOL-BREF
Time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42526925Nguyen MND, Le HTN, Nguyen TV, Do TP, Saussez G, Bleyenheuft Y. Parent-delivered Hand-arm Bimanual Intensive Training Including Lower Extremity for young children with bilateral cerebral palsy in Vietnam: protocol for a randomised controlled trial. BMJ Open. 2026 Jul 29;16(7):e113596. doi: 10.1136/bmjopen-2025-113596.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. and Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at home with the online guidance and supervision of experts. in people with Cerebral Palsy, run by Université Catholique de Louvain.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannick Bleyenheuft, Phd, Prof (+324869 99 11, Yannick.bleyenheuft@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure -66 (GMFM- 66) (time frame: Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline). The study lists 2 primary outcomes in all. 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 NCT06593158, which also lists 1 linked publication.
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 19 Sep 2024.