Clinical trial NCT06272760: Development of a Remote Therapy Protocol for Upper Limb Function Enhancement in Children With Cerebral Palsy
Official title: Development and Validation of a Remote Therapy Protocol Using Multimodal Sensor Fusion for Upper Limb Function Enhancement in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Physical activity
Telerehabilitation
Accelerometer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
Secondary outcomes:
measure: Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
measure: Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
measure: Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
measure: Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
measure: Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
measure: Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0).
timeFrame: Baseline and 1 month (post intervention)
measure: Quantitative Analysis of Ocular Motor Function Using a Wearable Eye-Tracking Device (Neon)
timeFrame: Baseline and 1 month (post intervention)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: JEONG-YI KWON, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: