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Effect of Robotic Gait on Functions in Cerebral Palsy

28 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

15

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Comportemental: 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).
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Selective Control Assessment of the Lower Extremity (SCALE)
Délai: 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)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Gross Motor Function Measure (GMFM-88)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Medipol University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 février 2022

Achèvement primaire (Réel)

15 décembre 2022

Achèvement de l'étude (Réel)

15 juin 2023

Dates d'inscription aux études

Première soumission

12 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 avril 2026

Dernière vérification

1 janvier 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • E-10840098-772.02-6173

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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