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Cerebral Palsy (CP)NCT07566767

Effect of Robotic Gait on Functions in Cerebral Palsy

A study testing Neurodevelopmental Treatment (NDT) and Robotic Gait Trainer in people with Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Cerebral Palsy (CP)
What is being tested?
Neurodevelopmental Treatment (NDT) and Robotic Gait Trainer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2022to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Medipol University, Physiotherapy and Rehabilitation Department

    Istanbul, Beykoz, 34810

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Neurodevelopmental Treatment (NDT), Robotic Gait Trainer
Keywords
Balance, Cerebral Palsy, Lower Extremity, Robotic Rehabilitation, Trunk
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurodevelopmental Treatment (NDT)Behavioural

    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).

  • Robotic Gait TrainerDevice

    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.

Study groups in NCT07566767
Study groupRoleWhat they receive
Single Group: Sequential Conventional Treatment and Experimental InterventionExperimentalParticipants 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).
Receives: Behavioral: Neurodevelopmental Treatment (NDT); Device: Robotic Gait Trainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 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)

  1. Gross Motor Function Measure (GMFM-88)

    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.

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

  2. Trunk Control Measurement Scale (TCMS)

    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).

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

  3. Time Up and Go Test (TUG)

    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.

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

  4. Becure Balance System

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start15 Feb 2022
  3. Primary completion15 Dec 2022
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07566767
Sponsor's protocol ID
E-10840098-772.02-6173
Status last verified
Jan 2022
First submitted
12 Apr 2026
Last updated
5 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared

Publications

  • 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.

    PubMed 28751254

  • 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.

    PubMed 24032716

  • 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.

    PubMed 36156543

  • 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.

    PubMed 21343525

  • 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.

    PubMed 32444573

  • 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.

  • 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.

  • 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.

    PubMed 30269804

  • 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.

    PubMed 35564511

  • 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.

    PubMed 26221161

  • 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.

    PubMed 32606703

  • 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.

    PubMed 21895642

Questions about this trial

What is this clinical trial studying?

A study testing Neurodevelopmental Treatment (NDT) and Robotic Gait Trainer in people with Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07566767, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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