The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury
Primary Purpose
Cerebral Palsy, Children With Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)
Conventional OT group
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring upper limb function, multi-IMU (inertial measurement unit) sensors, Melbourne Assessment of Unilateral Upper Limb Function (MUUL-2)
Eligibility Criteria
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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMU sensor training group(intervention group)
Conventional OT group (control group)
Arm Description
video-game based rehabilitation therapy system training group
conventional training group (control group)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02949817
Brief Title
The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Children With Brain Injury
Keywords
upper limb function, multi-IMU (inertial measurement unit) sensors, Melbourne Assessment of Unilateral Upper Limb Function (MUUL-2)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMU sensor training group(intervention group)
Arm Type
Experimental
Arm Description
video-game based rehabilitation therapy system training group
Arm Title
Conventional OT group (control group)
Arm Type
Active Comparator
Arm Description
conventional training group (control group)
Intervention Type
Device
Intervention Name(s)
digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional OT group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total score of Melbourne Assessment of Unilateral Upper Limb Function
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Total score of upper limb physician's rating scale (ULPRS)
Description
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.
Time Frame
8 week
Title
Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)
Description
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.
Time Frame
8 week
Title
Kinematic data of computerized 3D motion analysis
Description
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.
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury
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