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

NCT06593158 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

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.

* 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.

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.

* 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.

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    collaborator OTHER

  • Université Catholique de Louvain

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2026-08-01
Completion
2027-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593158 on ClinicalTrials.gov