The effect of home based occupational therapy using Rapael Smart Kids in children with brain injury: single blind randomized controlled study

The effect of home-based occupational therapy using Rapael Smart Kids (model no: KDH) on upper limb functions and safety in children and adolescent with brain injury (cerebral palsy, brain hemorrhage, infarction): Single blind, Randomized Controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003172

Enrollment

Registered

2018-09-10

Start date

2018-09-13

Completion date

Unknown

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : - Treatment time/ frequency: daily 30 minutes x 5 days per week x 6weeks - RAPAEL group : at least 30 minutes of home based upper extremity training for 6 weeks - control group: no

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? MACS (Manual ability classification system) level II, III, IV , Cerebral Palsy or Static Brain injury (6 months after the onset) ? MHFC (Modified House Functional Classification) level 4,5,6,7 ? male or female, 3 to 17 years 11months ? Patients without cognitive impairment who are able to comply with protocol-required procedure ? Voluntarily agreed and singed the consent

Exclusion criteria

Exclusion criteria: ? Significant mental retardation, hard to apply study device ? Significant visual impairment, hard to recognize screen ? Skin/ Musculoskeletal deformity, hard to wear study device ? Etc, The subject who is deemed unsuitable for this study ? Botulinum toxin therapy in the study limb within 6 months prior to the baseline assessment day or History of treatment with alcohol block or orthopedic surgery in the study limb within 12 months prior to the baseline assessment day ? Severe dizziness or nausea and vomiting symptom during the intervention

Design outcomes

Primary

Measure	Time frame
Total score of Melbourne Assessment of Unilateral Upper Limb Function (MULL)	—

Secondary

Measure	Time frame
Kinematic data of computerized 3D motion analysis;Upper Limb Physician's Rating Scale (ULPRS);Pediatric Evaluation of Disability Inventory (PEDI);Side Effect or Adverse Event	—

Countries

Korea, Republic of

Contacts

Public ContactJA YOUNG CHOI

Eulji University Hospital

Outcome results