Effect of Robotic Gait on Functions in Cerebral Palsy

NCT07566767 | Completed

• 1 other identifier: E-10840098-772.02-6173
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy (CP)

Keywords

Balance; Cerebral Palsy; Lower Extremity; Robotic Rehabilitation; Trunk

Outcome Measures

Primary Outcomes (2)

• Selective Control Assessment of the Lower Extremity (SCALE)

  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)

  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 Outcomes (4)

• Gross Motor Function Measure (GMFM-88)

  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)

  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)

  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

  Baseline (T0), after 4 weeks of NDT intervention (fourth week - T1) and after 4 weeks of NDT+RB intervention (tenth week - T2)

Study Arms (1)

Single Group: Sequential Conventional Treatment and Experimental Intervention

EXPERIMENTAL

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); Device: Robotic Gait Trainer

Interventions

Neurodevelopmental Treatment (NDT) BEHAVIORAL

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).

Single Group: Sequential Conventional Treatment and Experimental Intervention

Robotic Gait Trainer DEVICE

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.

Single Group: Sequential Conventional Treatment and Experimental Intervention

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University, Physiotherapy and Rehabilitation Department

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (12)

• Carvalho I, Pinto SM, Chagas DDV, Praxedes Dos Santos JL, de Sousa Oliveira T, Batista LA. Robotic Gait Training for Individuals With Cerebral Palsy: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Nov;98(11):2332-2344. doi: 10.1016/j.apmr.2017.06.018. Epub 2017 Jul 24.

  PMID: 28751254 RESULT

• El-Shamy SM, Abd El Kafy EM. Effect of balance training on postural balance control and risk of fall in children with diplegic cerebral palsy. Disabil Rehabil. 2014;36(14):1176-83. doi: 10.3109/09638288.2013.833312. Epub 2013 Sep 13.

  PMID: 24032716 RESULT

• Gulzar A, Waris M; Qurat Ul Ain. Effects of 8 weeks functional training programme on posture control and functional mobility in spastic hemiplegic cerebral palsy. J Pak Med Assoc. 2022 Jul;72(7):1278-1281. doi: 10.47391/JPMA.3476.

  PMID: 36156543 RESULT

• Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22.

  PMID: 21343525 RESULT

• Ammann-Reiffer C, Bastiaenen CHG, Meyer-Heim AD, van Hedel HJA. Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT). J Pediatr Rehabil Med. 2020;13(2):137-148. doi: 10.3233/PRM-190614.

  PMID: 32444573 RESULT

• Klobucka, S., Ziakova, E., & Klobucky, R. (2015). P178-2253: The effect of age on the improvement in motor function in patients with cerebral palsy after undergoing robotic-assisted locomotor therapy. European Journal of Paediatric Neurology, 19, S143-S144.

  RESULT

• Tarakcı, D., Emir, A., Avcıl, E., & Tarakcı, E. (2019). Effect of robot assisted gait training on motor performance in cerebral palsy: a pilot study. Journal of Exercise Therapy and Rehabilitation, 6(3), 156-162.

  RESULT

• Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.

  PMID: 30269804 RESULT

• Llamas-Ramos R, Sanchez-Gonzalez JL, Llamas-Ramos I. Robotic Systems for the Physiotherapy Treatment of Children with Cerebral Palsy: A Systematic Review. Int J Environ Res Public Health. 2022 Apr 22;19(9):5116. doi: 10.3390/ijerph19095116.

  PMID: 35564511 RESULT

• Labaf S, Shamsoddini A, Hollisaz MT, Sobhani V, Shakibaee A. Effects of Neurodevelopmental Therapy on Gross Motor Function in Children with Cerebral Palsy. Iran J Child Neurol. 2015 Spring;9(2):36-41.

  PMID: 26221161 RESULT

• Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.

  PMID: 32606703 RESULT

• Reid SM, Modak MB, Berkowitz RG, Reddihough DS. A population-based study and systematic review of hearing loss in children with cerebral palsy. Dev Med Child Neurol. 2011 Nov;53(11):1038-45. doi: 10.1111/j.1469-8749.2011.04069.x. Epub 2011 Sep 6.

  PMID: 21895642 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: May 5, 2026
• Study Start: February 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: June 15, 2023
• Last Updated: May 5, 2026

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)