Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam

NCT06593158 | Not Yet Recruiting DMC

• 1 other identifier: Parent-delivered HABIT-ILE
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Cerebral Palsy

Keywords

HABIT-ILE; Cerebral Palsy; Caregiver -delivered; Intensive therapy; Home rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  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)

  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)

  Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline

• WHOQOL-BREF

  Two weeks before baseline, at baseline, at the end of the two-weeks intervention, and 3 months after baseline

Study Arms (2)

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.

Interventions

Parent-delivered Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) for CP children at camp with the guidance and supervision of experts. BEHAVIORAL

* 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.

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. BEHAVIORAL

* 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.

HABIT-ILE at Home with Caregivers

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Université Catholique de Louvain: lead
• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Yannick Bleyenheuft, Phd, Prof

CONTACT

+324869 99 11; Yannick.bleyenheuft@uclouvain.be

Doan MN Nguyen, Phd

CONTACT

+84 392332846; doan.nguyen@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcomes: The Gross Motor Function Measure (GMFM-66), Melbourne Assessment 2 will be videotaped, and the scoring will be done by blind trained examinors. In secondary outcomes: ACTIVLIM-CP-WA, PEDI, COPM, WHOQOL-Bref will be answered by the caregivers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share