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

NCT07469696 | Active Not Recruiting DMC

• 1 other identifier: e7LQWh2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; walking robot; neurodevelopmental exercise; ambulatory type cerebral palsy; technological rehabilitation

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure-88 (GMFM-88)

  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.

  12 week

Secondary Outcomes (4)

• Modified Ashworth Scale

  The treatment period was 3 months and spasticity values were re-examined at the end of 3 months.

• 6 minute walk test

  It covers the 3-month period from the beginning to the end of the treatment. 3 months includes 12 weeks. An evaluation will be made at the beginning and end of the 12 weeks.

• MIR SPIROBANK SPIROMETER

  Measurements will be taken at the end of 12 weeks.

• MIR SPIROBANK SPIROMETER

  Measurements will be taken at the end of 12 weeks.

Study Arms (2)

ROBOTIC REHABILITATION GROUP APPLIED IN ADDITION TO NEURODEVELOPMENTAL TREATMENT

EXPERIMENTAL

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.

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

Only neurodevelopmental exercise group

EXPERIMENTAL

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.

Device: spirometer spirobank

Interventions

robotic rehabilitation and intensive spirometry DEVICE

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.

ROBOTIC REHABILITATION GROUP APPLIED IN ADDITION TO NEURODEVELOPMENTAL TREATMENT

spirometer spirobank DEVICE

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.

Only neurodevelopmental exercise group; ROBOTIC REHABILITATION GROUP APPLIED IN ADDITION TO NEURODEVELOPMENTAL TREATMENT

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, 34279, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Efe ALCAN

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The study consists of 2 groups and is a randomized controlled trial. Each of the 2 groups consists of 12 patients. One group is a neurodevelopmental exercise group only and the other group is a group that receives robotic rehabilitation in addition to neurodevelopmental exercises. The groups were determined in a completely randomized manner.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: March 13, 2026
• Study Start: December 20, 2024
• Primary Completion: April 21, 2026
• Study Completion: May 22, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)