The Effect of Robot-assisted Walking Training on Motor Functions, Respiratory Parameters and Functional Capacity in Cerebral Palsy

Istanbul University - Cerrahpasa

Status: Active, not recruiting

Conditions: Cerebral Palsy (CP)

Treatments: Device: spirometer spirobank; Device: robotic rehabilitation and intensive spirometry

Study type: Interventional

Funder types: Other

Identifiers

NCT07469696

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Details and patient eligibility

About

An informed consent form was prepared for families regarding the planned research. Permission and signatures were obtained from the parents of children aged 8-16 years who participated in the study.

The study titled "The Effect of Robot-Assisted Walking Training on Motor Functions, Respiratory Parameters and Functional Capacity in Cerebral Palsy" is conducted by Physiotherapist Efe Alcan at the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul University-Cerrahpaşa. This master's thesis aims to evaluate motor functions, respiratory parameters, and functional capacity in daily life in children with ambulatory type Cerebral Palsy receiving neurodevelopmental treatment (NDT)-based exercises, with or without additional robot-assisted walking training.

The primary objective is to determine the effectiveness of adding robot-assisted gait training to conventional neurodevelopmental treatment on motor and respiratory parameters. The scientific contribution of the study is the quantitative measurement of FEV1, FVC, and FEV1/FVC values using a digital spirometer in children undergoing robot-assisted gait training, thereby providing objective pulmonary data in individuals with Cerebral Palsy.

Interventions include tandem walking, balance exercises, weight transfer exercises in hands-and-knees (cat-camel) position, and proprioceptive exercises. The experimental group additionally performs walking sessions using a robotic gait device. All interventions are supervised by Physiotherapist Efe Alcan and are not expected to involve significant risk.

Following completion of the 12-week intervention program, all baseline assessments are repeated to evaluate treatment-related changes.

A total of 24 children with Cerebral Palsy are expected to participate. Demographic data including age, sex, height, weight, education status, and relevant medical history are recorded at baseline. Participants attend two evaluation sessions (pre- and post-intervention) and a 40-minute rehabilitation session once weekly for 12 weeks.

Full description

Detailed Description

Cerebral Palsy (CP) is a group of permanent disorders affecting movement, posture, and motor control caused by non-progressive disturbances in the developing brain. In addition to motor impairments such as spasticity, muscle weakness, and impaired balance, children with CP frequently demonstrate reduced cardiopulmonary capacity and decreased endurance during daily activities. Limitations in trunk control, altered gait mechanics, and reduced physical activity levels may negatively influence respiratory function over time. For this reason, modern pediatric rehabilitation approaches increasingly emphasize interventions that address both motor performance and physiological capacity.

Neurodevelopmental treatment (NDT) is one of the most commonly used therapeutic approaches in pediatric neurorehabilitation. The approach focuses on facilitating normal movement patterns, improving postural control, enhancing functional mobility, and promoting participation in daily activities through task-specific exercises and therapist-guided movement strategies. Although NDT-based interventions are widely applied, complementary technologies that increase movement repetition and provide structured gait practice may further enhance rehabilitation outcomes.

Robot-assisted gait training has been developed to deliver repetitive, task-specific walking practice with controlled parameters such as walking speed and body alignment. These systems enable individuals with neurological impairments to practice symmetrical gait cycles while receiving external mechanical support and consistent sensory input. Such repetitive locomotor training may contribute to motor learning, improve walking ability, and potentially increase cardiopulmonary engagement during rehabilitation. However, evidence regarding the combined effects of robot-assisted gait training and conventional neurodevelopmental treatment on both motor and respiratory outcomes in children with Cerebral Palsy remains limited.

This study investigates the effects of adding robot-assisted gait training to a neurodevelopmental treatment-based rehabilitation program in ambulatory children with Cerebral Palsy. The intervention program is designed to target multiple components of functional performance, including postural control, balance, lower-extremity strength, coordination, and breathing mechanics. Participants are allocated into two intervention groups: a neurodevelopmental treatment group and a neurodevelopmental treatment plus robot-assisted rehabilitation group. Both interventions are administered by a physiotherapist experienced in pediatric neurological rehabilitation.

The neurodevelopmental treatment program consists of a structured series of exercises designed to improve trunk stability, balance control, and functional mobility. The exercise protocol includes diaphragmatic breathing training intended to facilitate respiratory muscle activation and improve breathing patterns. Balance and gait-related tasks are incorporated through tandem walking and step-length training, which aim to enhance dynamic stability and gait symmetry. Functional strengthening exercises include repeated sit-to-stand activities performed on a supported balance surface, which target lower-extremity muscle activation and postural transitions commonly used in daily activities.

Additional exercises focus on trunk and pelvic control. Pelvic elevation (bridging) exercises are used to strengthen the hip extensors and improve pelvic stability, while quadrupedal balance tasks with contralateral reaching challenge trunk coordination and postural control. Functional stepping activities performed using a step platform provide task-specific practice of stepping movements and weight transfer. Finally, weight-shifting activities in a seated position are performed with therapist-applied approximation to stimulate proprioceptive input and improve trunk alignment.

Participants in the experimental group perform a modified version of the same neurodevelopmental exercise sequence with reduced repetition volumes to maintain a similar overall session duration. Following completion of these exercises, the participants undergo robot-assisted gait training using a robotic walking system. During robotic training, the child walks with mechanical guidance provided by the device, which supports the lower extremities and facilitates repetitive gait cycles. The robotic walking session is performed under controlled conditions with a walking speed of 0.08 km/h and no treadmill inclination. The robotic component of the intervention provides additional locomotor practice and aims to reinforce coordinated walking patterns through high-repetition training.

The rehabilitation sessions are designed to provide a combination of respiratory activation, postural control exercises, and functional gait-related activities. Through repeated exposure to these activities, the program seeks to stimulate neuromuscular adaptation and improve movement efficiency. The integration of robotic gait training may further increase the amount of walking practice while ensuring safe and consistent movement patterns.

Pulmonary function is evaluated using digital spirometry to obtain objective measurements of respiratory performance. Spirometric assessment provides quantitative values reflecting airway function and respiratory capacity. The study focuses on key spirometric indicators that are commonly used to assess pulmonary performance in clinical and research settings. These objective respiratory measurements allow for the examination of potential physiological changes associated with gait training and increased physical engagement.

By combining conventional neurodevelopmental therapy with robotic locomotor training, this study aims to explore whether a technology-supported rehabilitation approach can enhance functional outcomes beyond those achieved through conventional therapy alone. The results are expected to contribute to the growing body of research investigating the integration of robotic technologies into pediatric neurorehabilitation and may provide insight into their potential influence on both motor and respiratory performance in children with Cerebral Palsy.

Enrollment: 24 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 8-18 years with a diagnosis of spastic type cerebral palsy (SP)
• Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
• Height ≥100 cm to ensure compatibility with robotic device braces
• Adequate cognitive and behavioral cooperation to participate in exercise sessions

Exclusion criteria

• Musculoskeletal surgery within the past 12 months
• Botulinum Toxin A injection within the past 6 months
• History of uncontrolled or irregular epilepsy/seizures
• Cardiovascular disease contraindicating exercise participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

ROBOTIC REHABILITATION GROUP APPLIED IN ADDITION TO NEURODEVELOPMENTAL TREATMENT

Experimental group

Description:

LOKOHELP Electromechanical Walking Device was used. This device was developed for locomotor therapy with body weight support on the treadmill. LokoHelp enables individuals to develop correct posture, walking and turning ability without human support. This system provides weight support to the individual and allows them to walk in the correct pattern. In the meantime, a monitor shows us the individual's speed and the distance they have covered in meters during their walk. In order to integrate the individual into the system, they were dressed in clothing and shoes that were appropriate to their measurements.

Treatment:

Device: spirometer spirobank

Device: robotic rehabilitation and intensive spirometry

Only neurodevelopmental exercise group

Experimental group

Description:

This group was given 40 minutes of neurodevelopmental exercises. These exercises are listed as follows: Balance was worked on by transferring weight to the hips and legs in different positions. Step strategies towards different directions were worked on. If the patient can do it fully, active, if not, active assisted tandem walking exercises were worked on. Balance exercises were done on a balance board.

Treatment:

Device: spirometer spirobank