Status:
NOT_YET_RECRUITING
Parent-delivered HABIT-ILE in Young Children With Cerebral Palsy in Vietnam
Lead Sponsor:
Université Catholique de Louvain
Collaborating Sponsors:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Cerebral Palsy
Eligibility:
All Genders
2-6 years
Phase:
NA
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 moto...
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, perc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06593158
Start Date
September 30 2024
End Date
August 1 2027
Last Update
September 19 2024
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