Clinical trial NCT05759182: The Effects of Exoskeletal Robot-Assisted Gait Training on Children With Cerebral Palsy: A Pilot Study
Official title: The Effects of Exoskeletal Robot-Assisted Gait Training on Children With Cerebral Palsy: An Open-label, Pre-Post Comparison Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Gait Disorders
Gait Disorders in Children
Gait Disorders, Neurologic
Spastic Cerebral Palsy
Dyskinetic Cerebral Palsy
Diplegia
Keywords: Cerebral Palsy
Exoskeleton
Gait
Walking
Lead sponsor: COSMO ROBOTICS CO., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hanyang University
First posted: 2023-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Single-Arm, Open-label, Pre-Post Comparison Study Design
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Cerebral Palsy (CP) is a complex neurodevelopmental disorder caused by early brain injury, leading to motor impairments such as muscle weakness, stiffness, and gait instability, which impact daily functioning. Gait training is crucial for improving mobility and independence in children with CP. Recently, robotic gait training (RAGT) devices, such as exoskeletons, have been explored as a rehabilitation tool. Although widely studied in adults, evidence of the effectiveness of RAGT in children with CP is limited. Preliminary studies have shown promising results in improving motor function and gait in children, yet more research is needed to validate its clinical efficacy comprehensively. This study aims to assess the impact of exoskeletal RAGT on daily activities, motor function, balance, and walking in adolescents with CP.

Detailed description: Cerebral Palsy(CP) is a complex disorder caused by brain lesions that affect muscle tone, posture, movement, and gait. It is a neurodevelopmental, non-progressive disease caused by brain injury before the age of 3(1). The damaged brain results in persistent disability throughout childhood and beyond.

Cerebral Palsy is characterized by motor impairment that results in decreased muscle strength in certain muscles, causing muscle weakness, stiffness, contractures, and fatigue(2, 3). These features lead to decreased coordination between the muscles required to perform motor skills, which prevents the heel strike during gait(4), resulting in decreased motor control of body segments, decreased stride length, and increased gait instability, all of which contribute to poor gait quality(5, 6). Gait training, one of the main rehabilitation goals to improve the quality of life for children with Cerebral Palsy, aims to improve standing, walking, running, and hopping motor skills to help them live independently(7, 8).

Various types of robotic gait training devices have been developed to treat children with Cerebral Palsy. They are categorized into two types, exoskeleton and end-effector, depending on their principle of operation. The exoskeleton type moves joints such as hip, knee, and ankle joints to match the gait cycle. On the other hand, the end-effector type moves the foot by moving the footplate on which the body is supported(9).

Robot-assisted gait training (RAGT), an emerging area of rehabilitation, was initially developed for adults using driven gait orthoses (DGOs)(10, 11). Since the 21st century, several studies have reported that robot-assisted gait training improves walking performance in people with stroke or spinal cord injury. One systematic literature review reported that it is effective for the above conditions, but there is insufficient evidence for traumatic brain injury or Parkinson's disease(12, 13).

The robotic gait training device Lokomat (Hocoma, AG, Volketswil, Switzerland) has released a pediatric version of the gait training robot(14-16) to start gait training for children around four years of age. The usability of robotic gait training has been tested in the neurorehabilitation of pediatric diseases over the past several years. It was recently found that robotic gait training is a safe intervention method for children(17, 18). However, there is currently a significant lack of evidence regarding the clinical effectiveness of robotic gait training for various pediatric patient populations.

A recent study conducted at a university hospital reported improvements in gross motor function, gait speed, and endurance with reduced energy expenditure following robotic gait training (Angel-legs, ANGEL ROBOTICS Co., Ltd., Seoul, Korea) for three children with cerebral palsy (ages 9, 13, and 16). Additionally, for two children with ataxic cerebral palsy (ages 11 and 12), combining conventional intensive rehabilitation therapy with robotic gait training led to reported improvements in gross motor function, functional balance, and walking ability(20).

However, there is still a lack of evidence on robotic gait training for various pediatric diseases, and no studies have been conducted to demonstrate its effectiveness through various evaluations. Therefore, we aimed to investigate the effects of exoskeleton robotic gait training on activities of daily living, gross motor function assessment, balance, and walking ability in adolescents with Cerebral Palsy.

Eligibility criteria: \[Inclusion Criteria\]

1. Patients with spastic cerebral palsy aged between 3 and 18 years.
2. Patients with gait disturbances due to lower limb weakness.

\[Exclusion Criteria\]

1. Patients unable to understand and follow instructions.
2. Patients with severe lower limb spasticity scoring 3 or higher on the Modified Ashworth Scale.
3. Patients with severe gait disorders, scoring at or below Level 1 on the Functional Ambulation Category (FAC).
4. Patients with lower limb contractures, deformities, skin issues, neurological comorbidities other than cerebral palsy, or cardiovascular and other medical issues that may affect the ability to wear and walk with a robotic exoskeleton device.
5. Patients who refuse to participate in the study.

Primary outcomes:
measure: Number of Participants with Improved Physical Activity
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Score on Gross Motor Function Measure (GMFM)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Classification Level on Gross Motor Function Classification System (GMFCS)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Time to Complete the Timed Up and Go Test (TUG)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Distance Covered in the Six-Minute Walk Test (6MWT)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Score on Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Score on Korean Version of Cerebral Palsy Quality of Life Questionnaire (K-CP-Qol)
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Assessment on Skin Condition Changes
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Level of Spasticity Assessment
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Risk Analysis - Adverse Event Incidence Rate
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Rate of change in pain level
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Seongdong
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul
Study officials:
affiliation: Department of Rehabilitation Medicine, Hanyang University Seoul Hospital
name: Kyuhoon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
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