NCT02949817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

March 14, 2016

Last Update Submit

July 17, 2018

Conditions

Cerebral PalsyChildren With Brain Injury

Keywords

upper limb functionmulti-IMU (inertial measurement unit) sensorsMelbourne Assessment of Unilateral Upper Limb Function (MUUL-2)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Total score of upper limb physician's rating scale (ULPRS)

    8 week

  • Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)

    8 week

  • Kinematic data of computerized 3D motion analysis

    8 week

Study Arms (2)

IMU sensor training group(intervention group)

EXPERIMENTAL

video-game based rehabilitation therapy system training group

Device: digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)

Conventional OT group (control group)

ACTIVE COMPARATOR

conventional training group (control group)

Other: Conventional OT group

Interventions

digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)DEVICE

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.

IMU sensor training group(intervention group)
Conventional OT groupOTHER

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.

Conventional OT group (control group)

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

October 31, 2016

Study Start

July 24, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)