Development and Validation of a Remote Therapy Protocol Using Multimodal Sensor Fusion for Upper Limb Function Enhancement in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single blinding
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Tele-HABIT
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.
Intervention: Home-based hand-arm bimanual intensive training (Tele-HABIT) (Other)
Control
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.
Outcomes
Primary Outcomes
Change from Assisting Hand Assessment (AHA) score at post-intervention test (T1-T0).
Time Frame: Baseline and 1 month (post intervention)
AHA is a standardized tool for children(18 months-12 years) with unilateral CP. The AHA measures the child's ability to use the affected hand to assist the unaffected hand in a variety of bimanual activities. The 15-20 minute session uses semi-structured play with specific items. A certified AHA assessor views the videorecording to score the child's displayed willingness and ability to use the weaker arm and hand on each of 22 items from 1 (= does not do) to 4 (= effective). The AHA has inter- and intra-rater reliabilities of 0.98 and 0.97 respectively and content validity established during initial development. For data analysis, we generated AHA Logit scores (as recommended in the administration manual) that transform the raw (ordinal) scores into interval level data.
Secondary Outcomes
- Change from Baseline Pediatric Motor Activity Log (PMAL) score at post-intervention test (T1-T0).(Baseline and 1 month (post intervention))
- Change from Baseline Melbourne Assessment 2 (MA2) score at post-intervention test (T1-T0).(Baseline and 1 month (post intervention))
- Change from Canadian Occupational Performance Measure (COPM) score at post-intervention test (T1-T0).(Baseline and 1 month (post intervention))
- Change from Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) score at post-intervention test (T1-T0).(Baseline and 1 month (post intervention))
- Change from baseline Magnitude ratio (Accelerometer) at post-intervention test (T1-T0).(Baseline and 1 month (post intervention))
- Change from baseline Bilateral magnitude(Accelerometer) at post-intervention test (T1-T0).(Baseline and 1 month (post intervention))
- Quantitative Analysis of Ocular Motor Function Using a Wearable Eye-Tracking Device (Neon)(Baseline and 1 month (post intervention))
Investigators
Jeong Yi Kwon
Professor
Samsung Medical Center