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

NCT ID: NCT02949817

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2018-02-01

Brief Summary

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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

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* 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

Conditions

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Cerebral Palsy Children With Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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IMU sensor training group(intervention group)

video-game based rehabilitation therapy system training group

Group Type EXPERIMENTAL

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

Intervention Type 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.

Conventional OT group (control group)

conventional training group (control group)

Group Type ACTIVE_COMPARATOR

Conventional OT group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1-2015-0097

Identifier Type: -

Identifier Source: org_study_id

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