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Effect of Robotic Gait on Functions in Cerebral Palsy

28 aprile 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

15

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).
Comportamentale: 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).
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Selective Control Assessment of the Lower Extremity (SCALE)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gross Motor Function Measure (GMFM-88)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medipol University

Pubblicazioni e link utili

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Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 febbraio 2022

Completamento primario (Effettivo)

15 dicembre 2022

Completamento dello studio (Effettivo)

15 giugno 2023

Date di iscrizione allo studio

Primo inviato

12 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 aprile 2026

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E-10840098-772.02-6173

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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