Robot Assisted Gait Training In Children With Cerebral Palsy

NCT ID: NCT05540990

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2023-07-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group

This group will receive 15 sessions of robot-assisted gait training (two or three times per week with a maximum of 45 minutes each) and conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Group Type: EXPERIMENTAL

Robot assisted gait training

Intervention Type: DEVICE

15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).

Conventional physiotherapy

Intervention Type: OTHER

individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Conventional physiotherapy (CPt) group

This group will receive conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: OTHER

individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Interventions

Robot assisted gait training

15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).

Intervention Type: DEVICE

Conventional physiotherapy

individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• GMFCS Level 2-4
• Bilateral or unilateral spastic CP
• Able to follow instructions and communicate pain or discomfort
• Have a passive range of motion (ROM) of hips and knees within minimum range requirement for robotic assisted training (hip and knee flexion contracture ≤10°, and knee valgus ≤40°)
• Not having participated in another robotic assisted training regime within the previous 6 months
• Able to participate in a minimum of 30 minutes robotic assisted training session
• Able to commit to attendance of two to three times weekly for 15 sessions (to support the primary efficacy analysis)

Exclusion Criteria

• Botulinum toxin type A injection within 3 months
• Orthopedic surgery on the lower extremity (muscle surgery within the last 9 months, bone surgery within 12 months)
• Bone fractures, open skin lesions, or circulatory problems
• Vision and hearing impairments that affect participation in robotic assisted training
• Epilepsy resistant to medication
• Cardiopulmonary instability
• Use of a baclofen pump

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Birkan Sonel Tur

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birkan Sonel Tur, Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara University

Locations

Ankara University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

İ5-310-21

Identifier Type: -

Identifier Source: org_study_id