The Effects of Exo-Skeletal Robot-Assist Gait Training on Cerebral Palsy: A Pilot Study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0010057

Enrollment

Registered

2024-12-17

Start date

2024-09-02

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

None listed

Interventions

FPRS), and spasticity evaluation (Modified Ashworth Scale

Medical Device, Others(Exoskeletal Robot-Assisted Gait Training (Bambini teens EBS010, Cosmorobotics, Seoul, Korea) ) : A study will be conducted on 10 patients with cerebral palsy and gait impairment

MAS). A midterm evaluation will be conducted after 3 weeks (6 sessions), using the same assessments: physical activity measurement with an accelerometer, GMFM, GMFCS, 6MWT, TUG, K-CP-QoL, and Borg RPE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with spastic cerebral palsy aged between 3 and 18 yearsbased on MRI or CT - Patients with a spasticity assessment score (Modified Ashworth Scale) of less than 3 - Patients with a Functional Ambulation Classification (FAC) score of 2 or higher - Patients without lower limb contractures, deformities, skin issues, neurological comorbidities other than cerebral palsy, or cardiovascular and other medical conditions that could interfere with the use of the robotic gait device - Patients and their guardians who have signed the informed consent form for participation in the study

Exclusion criteria

Exclusion criteria: - Patients with cerebral palsy who do not have gait impairments - Patients with significantly reduced ability to follow instructions for study participation - Patients who have refused to participate in the study

Design outcomes

Primary

Measure	Time frame
Accelerometer;Gross motor functioin measure (GMFM);Gross motor function classification system (GMFCS);Six-minute Walk Test (6MWT);Pediatric Evaluation of Disability Inventory (PEDI);Timed Up and Go (TUG)	—

Secondary

Measure	Time frame
Recording of falls and malfunctions/errors of the robotic gait device;a general evaluation of skin condition, including bruising, swelling, erythema, and edema;Wong-Baker face pain rating scale (FPRS);Modified Ashworth Scores (MAS);Pediatric Quality of Life Inventory (PedsQL)	—

Countries

Korea, Republic of

Contacts

Public ContactWon-Cheol Kim

Hanyang University Seoul Hospital

saiphsoul@hanmail.net+82-2-2290-9363

Outcome results