Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy

Samsung Medical Center

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: Home-based hand-arm bimanual intensive training (Tele-HABIT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06272760

2024-02-060

Details and patient eligibility

About

The perpose of this study: Development and demonstration of a teletherapy protocol to improve upper limb function in children with cerebral palsy.

Full description

• Development of a home-based remote upper limb function evaluation program using heterogeneous (multimodal) sensors.
• Development of a home-based remote upper limb function improvement treatment program using heterogeneous sensors.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 6 to 12 years
• MACS level 1-4
• Diagnosed with CP due to central nervous system lesions

Exclusion criteria

• Individuals with a Manual Ability Classification System (MACS) level V, indicating an inability to use both hands in daily life activities.
• Individuals who fall within levels 0 to 4 of the House Functional Classification System.
• Individuals with severe intellectual disabilities, characterized by difficulties in understanding or following instructions.
• Individuals with vision impairment that could affect participation in the therapy.
• Individuals who have received a botulinum toxin injection in the upper extremity within the past 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Tele-HABIT

Experimental group

Description:

Children in the experimental group are going to receive intensive bimanual activity-based occupational therapy, known as Home-Based HABIT (H-HABIT). This therapy is going to be administered remotely. Each session will last for 2 hours and was conducted 5 times a week. The total duration of this intervention is 3 weeks.

Treatment:

Other: Home-based hand-arm bimanual intensive training (Tele-HABIT)

Control

No Intervention group

Description:

Children in the control group will not receive any intervention during the 3-week study period. They will be placed on a waitlist and offered the same therapy after the study is completed.