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

Yonsei University logo

Yonsei University

Status

Completed

Conditions

Cerebral Palsy
Children With Brain Injury

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02949817
1-2015-0097

Details and patient eligibility

About

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.

Full 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

Enrollment

40 patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

IMU sensor training group(intervention group)
Experimental group
Description:
video-game based rehabilitation therapy system training group
Treatment:
Device: digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)
Conventional OT group (control group)
Active Comparator group
Description:
conventional training group (control group)
Treatment:
Other: Conventional OT group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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