The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury

Cerebral Palsy Clinical Trial

Official title:

The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury: Single Blind Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949817
• Other study ID #: 1-2015-0097
• Status: Completed
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. First, the investigators would compare the effect of video-game based rehabilitation therapy to conventional occupational therapy.

Description:

• Purpose: to elucidate the effect of video-game based rehabilitation therapy system on upper limb function of children with cerebral palsy compared to conventional occupational therapy

• Subjects: total 30 children with cerebral palsy whose upper limb functions are impaired (all 30 children will receive the conventional occupational therapy, but 15 of these children will receive the additional video-game based rehabilitation therapy)

• Intervention: 4 weeks of therapy (6 days per week)

• Studies: functional MRI, computerized motion analysis, upper limb functional assessment (MUUL, ULPRS), ADL evaluation, cognitive evaluation

• Evaluation plan: 1) pre-intervention, 2) post-4 weeks of intervention, 3) 8 weeks after end of intervention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• MACS (Manual ability classification system) level I, II, III, IV

• Patients without cognitive impairment who are able to comply with protocol-required procedure

• male or female, 4 to 18 years

Exclusion Criteria:

• Patients with cognitive impairment who are unable to comply with protocol-required procedure

• Patients with significant visual impairment

• Patients with presence or history of musculoskeletal anomaly who are unable to apply device

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Palsy
• Children With Brain Injury
• Wounds and Injuries

Intervention

Device:
• digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)
1.The Rapael kids, a video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea will be used on upper limb function of children with pediatric brain injury patients. 20 of All 40 children will receive the conventional occupational therapy and additional video-game based rehabilitation therapy, 30 minutes daily 5 times per week, for 4 weeks.

Other:
• Conventional OT group
2. Conventional OT group will recieve the conventional occupational therapy and one more conventional occupational therapy additionally. The additional occupational therapy training will be performed 30 minutes daily 5 times per week, for 4 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of Melbourne Assessment of Unilateral Upper Limb Function	MUUL is the test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Scoring is completed for the 30 item scores using a three, four or five point scale and the individually defined scoring criteria. The test will be done by occupational therapist. The total score of MUUL will be used for analysis.	8 weeks
Secondary	Total score of upper limb physician's rating scale (ULPRS)	ULPRS assess changes in the movement pattern, focusing on all 3 levels of the arm (palm, forearm, and elbow) to determine whether there is an isolated functional impairment, such as thumb in palm, restricted forearm supination, or a total flexion pattern with thumb in palm, wrist in flexion, forearm supinated, and elbow flexed. The score sheet includes 9 items, and 3-, 4-, and 5-point scales are used to score each component of movement tested. The total score of ULPRS will be used for analysis.	8 week
Secondary	Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)	PEDI is a descriptive measure of a child's current functional performance. It measures both capability and performance of functional activities in three content domains: Self-care, Mobility, Social function. PEDI-selfcare section will be administered by occupational therapist. The Scaled scores of PEDI-selfcare will be used for analysis.	8 week
Secondary	Kinematic data of computerized 3D motion analysis	3D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup. Kinematic data of forearm pronation or supination, wrist flexion or extension, ulnar deviation or radial deviation will be used for analysis.	8 week