NCT05540990

Robot Assisted Gait Training In Children With Cerebral Palsy

The Effectiveness of Robot Assisted Gait Training In Children With Cerebral Palsy: Randomized Comparative Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Cerebral Palsy (CP) is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. CP primarily affects body movement and muscle coordination. Robot assisted gait training (RAGT) is considered to be a promising approach for improving gait related gross motor function of children and youth with CP. There is weak and inconsistent evidence regarding the use of RAGT for children with gait disorders. Further research is required with increased numbers and with relevant outcome measures to both confirm the effectiveness and clarify training schedules. The aim of this research project is to investigate the effectiveness of robot assisted gait training on improvements of functional gait parameters in children with cerebral palsy.

Detailed description

Cerebral Palsy (CP) is a disorder of posture and movement due to a defect in the immature brain. There is evidence that locomotor therapy for regaining walking capacity using the principle of enhancing neuroplasticity by task-specific training is effective in the rehabilitation process of patients with central gait disorders. The use of a robotic device assists in achieving and maintaining physiological walking pattern for extended periods of therapy. The use of robotic devices as an alternative treatment to improve the gait function in patients with CP has increased. This is a prospective, randomized comparative trial (RCT). This study is designed to compare the effectiveness of conventional physical therapy (CPt) and robot assisted gait training (RAGT) on gait related motor skills of children with cerebral palsy. Children aged 5 to 18 years with GMFCS Level 2-4, bilateral or unilateral spastic CP are accepted into this study. Participants are randomly assigned to receive CPt or RAGT + CPt. All two intervention groups will receive 2-3 sessions of CPt per week over 6-8 weeks. CPt sessions are individually customized to the needs of the child. The participants of RAGT + CPt group also receive 15 sessions of RAGT (2-3 times per week with a maximum of 45 minute each).

Conditions

• Cerebral Palsy
• Physical Therapy
• Robotic Rehabilitation
• Motor Skills Disorders

Interventions

Type	Name	Description
DEVICE	Robot assisted gait training	15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).
OTHER	Conventional physiotherapy	individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2022-09-15
• Last updated: 2024-02-08

Locations

1 site across 1 country: Turkey (Türkiye)