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

NCT07469696 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-12-20
Last updated
2026-03-13

Condition(s) studied

Cerebral Palsy (CP)

Investigational drug(s) / intervention(s)

robotic rehabilitation and intensive spirometryspirometer spirobank

robotic rehabilitation and intensive spirometry: The difference of this study from other studies is that lung functions were not evaluated in robotic rehabilitation applied in addition to neurodevelopmental treatment in previous studies in the literature. Expiratory muscle strength such as FEV1 / FVC was evaluated in children with robotic rehabilitation applied in addition to the exercise group with microquark spirometry.

spirometer spirobank: Spirometry evaluation will be performed on both groups and FEV1/FVC values will be checked after the exercises. Spasticity assessment will also be performed with modified ashwort. Knee flexors, knee extensors and ankle plantar flexors will be evaluated in both groups at the beginning and end of the treatment.

Study summary

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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Gross Motor Function Measure-88 (GMFM-88) — 12 week
    A total of 88 items are examined in 5 main dimensions: Area Content A Reaching and rolling B Sitting C Crawling and kneeling D Standing E Walking, running and jumping Each item is scored between 0-3 according to how successfully the child performs the task: 0: Cannot do 1 : Partially does 2: Almost completely does 3 : Fully does Determining the level of gross motor function Planning the rehabilitation process Monitoring progress over time and response to therapy Used to provide comparative measurement in clinical research.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University - Cerrahpasa Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469696 on ClinicalTrials.gov ↗ ← All trials in Turkey