Effect of Robotic Gait on Functions in Cerebral Palsy

April 28, 2026 updated by: Sevgi Acar, Medipol University

The Effects of Robotic Rehabilitation in Addition to Neurodevelopmental Therapy on Lower Extremity and Trunk Functions in Children With Cerebral Palsy

Cerebral palsy (CP) is a condition characterized by various motor disorders and limitations caused by brain damage. Neurodevelopmental treatment (NDT) is one of the primary approaches in the rehabilitation of individuals with CP. In recent years, technological rehabilitation methods, including robotic rehabilitation, have become more widespread. This study aimed to investigate the effects of robotic rehabilitation applied in addition to neurodevelopmental treatment on the lower extremity and trunk functions in children with CP. Fifteen children with CP participated in the study. The motor levels of the participants were assessed using the Gross Motor Function Classification System (GMFCS), gross motor functions with the Gross Motor Function Measure (GMFM-88), spasticity with the Modified Ashworth Scale (MAS), sitting balance with the Seated Postural Control Measure (SPCM) and Trunk Control Measurement Scale (TCMS), balance with the Becure Balance System and Timed Up and Go Test, and selective motor control with the Selective Control Assessment of the Lower Extremity (SCALE). After these assessments, the participants received NDT five times a week for a total of 20 sessions, each lasting 45 minutes, followed by reevaluation. After a two-week break, robotic rehabilitation was applied in addition to NDT for 20 sessions, with each session lasting 25 minutes, and evaluations were repeated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Beykoz
      • Istanbul, Beykoz, Turkey (Türkiye), 34810
        • Istanbul Medipol University, Physiotherapy and Rehabilitation Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with cerebral palsy
  • Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
  • Lower extremity Modified Ashworth Scale (MAS) score of 3 or less
  • No skin lesions or active skin infections in the lower extremities
  • Minimum height of 110 cm

Exclusion Criteria:

  • History of lower extremity orthopedic surgery
  • History of botulinum toxin type A (BTX-A) injection within the past 6 months
  • History of epileptic seizures
  • Inability to attend the intervention sessions regularly or maintain study
  • Inability to understand and follow simple verbal commands
  • Inability to establish and maintain cooperation during assessments and interventionscompliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group: Sequential Conventional Treatment and Experimental Intervention
Participants followed a single-group sequential intervention design. After baseline assessment (T0), participants received neurodevelopmental treatment (NDT) for 4 weeks (20 sessions, 5/week, 45 min), including weight-shifting exercises, facilitation techniques, sensory stimulation, strengthening, and proprioceptive training. Assessments were repeated at Week 4 (T1). After a 2-week washout period, participants underwent a combined intervention of NDT (20 min) and robotic rehabilitation (RB, 25 min) for 4 weeks (20 sessions, 5/week). RB was performed using the LokoHelp Gait Trainer, a body-weight-supported treadmill system enabling gait training with adjustable speed and incline based on tolerance. Final assessments were conducted at Week 10 (T2).
Behavioral: Neurodevelopmental Treatment (NDT)
Neurodevelopmental treatment (NDT) was applied as a conventional physiotherapy program focusing on facilitating normal movement patterns and improving postural control. Each session lasted 45 minutes and included weight-shifting exercises in crawling, sitting, kneeling, and standing positions; facilitation techniques; proprioceptive, auditory, and visual stimulation; isolated strengthening exercises for upper and lower extremities; and proprioceptive training. The intervention was delivered 5 times per week for 4 weeks (total of 20 sessions).
Device: Robotic Gait Trainer
Robotic rehabilitation (RB) was administered using the LokoHelp Gait Trainer, a body-weight-supported treadmill system designed for locomotor training. The device enables gait practice with appropriate posture and movement patterns without continuous manual assistance. Each session included 25 minutes of robotic-assisted gait training, with speed and incline adjusted according to participant tolerance. RB was applied 5 times per week for 4 weeks (total of 20 sessions) in combination with neurodevelopmental treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Selective Control Assessment of the Lower Extremity (SCALE)
Time Frame: Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Selective motor control was assessed using the Selective Control Assessment of the Lower Extremity (SCALE). SCALE evaluates selective voluntary motor control of the hip, knee, ankle, subtalar, and toe joints bilaterally. Participants were instructed to perform each movement within 3 seconds. Each joint was scored based on performance as follows: normal selective motor control (2 points), impaired selective motor control (1 point), and inability to perform selective motor control (0 points). The total score was calculated by summing the scores of all joints. The maximum possible score is 20 points (10 points for each extremity), and the minimum score is 0. Higher scores indicate better selective motor control.
Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
The Seated Postural Control Measure (SPCM)
Time Frame: Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Seated postural control was assessed using the Seated Postural Control Measure (SPCM). The scale evaluates postural alignment and functional performance in the sitting position. It consists of three sections: demographic information, postural alignment during sitting, and upper extremity function. Postural deviations are rated on a 4-point scale (1 = poor, 4 = good), with higher scores indicating better postural control. The maximum score is 88 for the postural alignment section and 48 for the upper extremity function section.
Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure (GMFM-88)
Time Frame: Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Gross motor function was assessed using the Gross Motor Function Measure-88 (GMFM-88). The scale consists of 88 items grouped into five domains: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running, and jumping (24 items). It is used to evaluate and classify functional motor abilities in children with motor impairments. Each item is scored on a 4-point scale ranging from 0 to 3. The maximum possible score is 264, and the minimum score is 0. Higher scores indicate better gross motor function and greater levels of functional independence.
Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Trunk Control Measurement Scale (TCMS)
Time Frame: Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Trunk control was assessed using the Trunk Control Measurement (TCMS), which evaluates both static and dynamic sitting balance. The scale consists of two main domains subdivided into three sections with a total of 15 items. It includes two items assessing static sitting balance and one domain assessing dynamic sitting balance parameters. The total score ranges from 0 to 58, with higher scores indicating better trunk control. Assessments were performed with children seated in a standardized position (hips and knees in 90° flexion, feet in contact with the ground, and without back support).
Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Time Up and Go Test (TUG)
Time Frame: Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Functional mobility, gait speed, postural balance, and dynamic stability were assessed using the Timed Up and Go (TUG) test. Participants were instructed to stand up from a standard chair, walk 3 meters, turn around, walk back to the chair, and sit down again. The total time required to complete the task was recorded in seconds. The test was performed twice, and the best performance was used for analysis. Higher completion time indicates poorer functional mobility and balance performance.
Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Becure Balance System
Time Frame: Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)
Static balance was assessed using a computerized balance platform system providing objective postural stability data. Participants stood on a balance board in a double-leg stance for 30 seconds under two conditions: eyes open and eyes closed. The system recorded center of pressure (CoP) displacement in the X-Y plane and postural sway area during standing. Outcome variables included postural sway parameters reflecting static balance control. Higher sway values indicate poorer postural stability.
Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

December 15, 2022

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

April 12, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-6173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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