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Clinical Trials/NCT02949817
NCT02949817
Completed
Not Applicable

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

Yonsei University1 site in 1 country40 target enrollmentJuly 24, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Yonsei University
Enrollment
40
Locations
1
Primary Endpoint
Total score of Melbourne Assessment of Unilateral Upper Limb Function
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 24, 2017
End Date
February 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Total score of Melbourne Assessment of Unilateral Upper Limb Function

Time Frame: 8 weeks

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 Outcomes

  • Total score of upper limb physician's rating scale (ULPRS)(8 week)
  • Kinematic data of computerized 3D motion analysis(8 week)
  • Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)(8 week)

Study Sites (1)

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