The Effect of Robot-assisted Walking Training on Motor Functions, Respiratory Parameters and Functional Capacity in Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy (CP)
Sponsor: Istanbul University - Cerrahpasa

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL OF THE STUDY 

Study Design and Participants 
This study will be conducted as a prospective randomized controlled trial including 
children diagnosed with spastic type Cerebral Palsy (CP). Participants must have an official 
medical board report confirming the diagnosis. 
Participation in the study will be voluntary. Written informed consent will be obtained from 
parents or legal guardians, and assent will be obtained from the children prior to inclusion 
in the study. 
All evaluation and treatment sessions will be carried out at Istanbul University-Cerrahpaşa. 
Participants who meet the eligibility criteria will be randomly assigned into two groups: 
 
Group I: Neurodevelopmental Treatment Group (NDT) 
 
Group II: Neurodevelopmental Treatment + Robotic Rehabilitation Group 
(NDT+RR) 
Randomization will be performed using a computer-generated randomization list. 
 
Sample Size Calculation 
The sample size was calculated using G*Power 3.1 software based on a two-tailed Pearson 
correlation analysis to evaluate concurrent validity. 
Assuming an expected correlation coefficient of r ≥ 0.60, a significance level of α = 0.05, and 
a statistical power of 90%, the required total sample size was determined to be 24 
participants. 
 
Inclusion Criteria 
 
Aged 8–15 years 
 
Diagnosed with spastic diplegic or spastic hemiplegic Cerebral Palsy 
 
Classified as Gross Motor Function Classification System (GMFCS) Levels I–III 
 
Height greater than 100 cm 
 
Signed informed consent and voluntary participation forms 
 
Exclusion Criteria 
 
Orthopedic surgery within the last 12 months 
 
Botulinum toxin A injection within the last 6 months 
 
History of uncontrolled or irregular epilepsy/seizures 

 
Cognitive or communication impairments preventing understanding or following 
instructions 
 
Treatment Protocol 
Group I (Neurodevelopmental Treatment Group – NDT) 
Participants in Group I will receive a neurodevelopmental physiotherapy program aimed at 
improving trunk control, balance, and lower extremity stabilization. 
Exercise Protocol Applied to the NDT Group 
Exercise 
Order 
Exercise Name 
Application 
1 
Diaphragmatic Breathing Exercise 
10 inspirations – 10 expirations 
2 
Tandem Walking and Step Length 
Training 
10 repetitions (forward and backward) 
3 
Sit-to-Stand Exercise on Supported 
Balance Platform 
20 repetitions 
4 
Pelvic Elevation / Bridging Exercise 
30 repetitions 
5 
Quadrupedal Balance Training (hands 
and knees) 
15 repetitions of contralateral reaching 
6 
Functional Step Training Using Step 
Board 
15 step-ups 
7 
Weight Transfer in Sitting Position 
Approximation applied in all directions 
for 2 minutes 
 
Group II (Neurodevelopmental Treatment + Robotic Rehabilitation – NDT+RR) 
Participants in Group II will receive the same neurodevelopmental treatment program with 
reduced repetitions, combined with robotic-assisted gait training. 
Exercise Protocol Applied to the NDT+RR Group 
Exercise 
Order 
Exercise Name 
Application 
1 
Diaphragmatic Breathing Exercise 
10 inspirations – 10 expirations 

Exercise 
Order 
Exercise Name 
Application 
2 
Tandem Walking and Step Length 
Training 
5 repetitions (forward and 
backward) 
3 
Sit-to-Stand Exercise on Supported 
Balance Platform (BOSU) 
10 repetitions 
4 
Pelvic Elevation / Bridging Exercise 
15 repetitions 
5 
Quadrupedal Balance Training (hands and 
knees) 
7 repetitions of contralateral 
reaching 
6 
Functional Step Training Using Step 
Board 
7 step-ups 
7 
Weight Transfer in Sitting Position 
Approximation applied in all 
directions for 1 minute 
8 
Robotic Gait Training 
20 minutes 
 
Robotic Rehabilitation Protocol 
Robotic-assisted gait training will be performed using the Woodway Locomot robotic gait 
training system. 
Participants will be positioned in the robotic system under the supervision of a 
physiotherapist. 
Training parameters: 
 
Speed: 0.08 km/h 
 
Inclination: 0.0° 
 
Training duration: 20 minutes 
 
Treatment Frequency and Duration 
 
Sessions will be conducted twice per week 
 
Total intervention duration: 12 weeks 
 
All interventions will be performed individually by a physiotherapist 
 
Outcome Measures 

Assessments will be performed at two time points: 
 
Baseline (pre-treatment) 
 
Post-treatment (after 12 weeks) 
 
Evaluation Tools 
Gross Motor Function Classification System (GMFCS) 
The GMFCS will be used to determine the functional classification level of participants at 
baseline. 
 
Respiratory Function Assessment 
Respiratory function will be assessed using a MicroQuark USB PC-based spirometer. 
The following respiratory parameters will be evaluated: 
 
Forced Vital Capacity (FVC) 
 
Forced Expiratory Volume in 1 second (FEV1) 
 
FEV1/FVC ratio 
 
Gross Motor Function Measure (GMFM-88) 
Gross motor performance will be evaluated using the GMFM-88. 
The following dimensions will be assessed: 
 
Dimension C – Crawling and Kneeling 
 
Dimension D – Standing 
 
Dimension E – Walking, Running and Jumping 
 
Ethical Considerations 
 
Written informed consent will be obtained from parents or legal guardians. 
 
Consent will be obtained for the processing and use of personal data. 
 
The study will adhere to ethical principles for research involving pediatric 
populations. 
 
Statistical Analysis 

Statistical analysis will be conducted using SPSS software. 
 
Data distribution will be assessed using the Shapiro–Wilk test. 
 
Within-group comparisons will be analyzed using the paired t-test or Wilcoxon 
signed-rank test, depending on the distribution of the data. 
 
Between-group comparisons will be performed using the independent samples t-
test or Mann–Whitney U test. 
The level of statistical significance will be set at p < 0.05.