Effect of Treadmill Gait Training Combined With Conventional Physiotherapy on Gait Performance and Functional Mobility in Children With Bilateral Spastic Cerebral Palsy: A Randomized Controlled Trial (GAIT-CP)
21 juillet 2026 mis à jour par: Dr. Tehreem Jameel, Syeda Khatoon e Jannat Welfare Foundation
Cerebral palsy is a neurological condition that affects movement, muscle control, and walking ability in children.
Children with bilateral spastic cerebral palsy often experience increased muscle stiffness, difficulty with walking, reduced balance, and limited functional mobility.
This randomized controlled trial aims to evaluate whether treadmill gait training combined with conventional physiotherapy can improve walking ability, gross motor function, balance, and mobility compared with conventional physiotherapy alone.
Children with bilateral spastic cerebral palsy will receive a 12-week rehabilitation program, and changes in motor function, gait performance, spasticity, and walking endurance will be assessed before and after treatment.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Bilateral spastic cerebral palsy (CP) is associated with lower-limb spasticity, impaired motor control, abnormal gait patterns, reduced walking speed, and limitations in functional mobility. Task-specific repetitive locomotor training is an important component of pediatric neurorehabilitation, and treadmill gait training may enhance stepping practice and improve gait-related outcomes.
This assessor-blinded, parallel-group randomized controlled trial aims to evaluate the effect of treadmill gait training combined with conventional physiotherapy compared with conventional physiotherapy alone in children with bilateral spastic CP. Children aged 6-16 years with GMFCS Level I-III will be recruited from Syeda Khatoon e Jannat Trust Hospital.
Participants will be randomly allocated into two groups. The intervention group will receive treadmill gait training (30 minutes/session, 3 sessions/week for 12 weeks) in addition to conventional physiotherapy, including stretching, strengthening, balance training, and functional activities. The control group will receive conventional physiotherapy alone.
Outcomes will be assessed at baseline and after intervention using the Gross Motor Function Measure (GMFM-66) as the primary outcome, along with the 10 Meter Walk Test, Timed Up and Go Test, Pediatric Balance Scale, Modified Ashworth Scale, and 6 Minute Walk Test to evaluate gait performance, functional mobility, balance, spasticity, and walking endurance.
Type d'étude
Interventionnel
Inscription (Réel)
24
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
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 3800
- Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
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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
- Clinically confirmed diagnosis of bilateral spastic cerebral palsy.
- Aged 6 to 16 years.
- Classified as GMFCS Levels I-III.
- Able to stand independently, with or without support.
- Presence of clinically significant lower-limb spasticity, defined as Modified Ashworth Scale (MAS) score ≥2.
- Demonstrated ambulatory ability with Timed Up and Go (TUG) ≤10 seconds.
- Demonstrated walking ability with 6-Minute Walk Test (6MWT) distance of 50-500 meters at baseline.
- Able to understand simple verbal commands and participate in structured therapy sessions.
- Parent or legal guardian willing to provide written informed consent.
- Willing and able to attend the complete 12-week intervention protocol. Exclusion Criteria
- Botulinum toxin injection within the previous 6 months.
- Recent pharmacological intervention significantly affecting spasticity.
- Lower-limb orthopedic surgery within the previous 12 months.
- Severe intellectual disability (IQ <70) or inability to follow simple instructions required for therapy participation.
- Uncontrolled seizures, epilepsy, or other neurological conditions that could interfere with participation.
- Fixed musculoskeletal contractures limiting standing, stepping, or gait training.
- Cardiopulmonary, medical, or orthopedic conditions that contraindicate treadmill-based exercise.
- Current participation in another gait-training or rehabilitation research study.
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: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treadmill Gait Training + Conventional Physiotherapy
Participants will receive treadmill gait training combined with conventional physiotherapy for 12 weeks. Treadmill training will be provided for 30 minutes per session, 3 sessions per week (total 36 sessions). Treadmill speed, assistance level, and progression will be individually adjusted according to participant tolerance, gait quality, and safety. Sessions will be supervised by a qualified physiotherapist. The conventional physiotherapy program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities including sit-to-stand practice, stair training, and obstacle negotiation. |
A task-specific locomotor training intervention involving treadmill walking practice for 30 minutes per session, 3 sessions per week for 12 weeks, combined with conventional physiotherapy.
A rehabilitation program including stretching, strengthening, balance training, and functional activities aimed at improving mobility and motor function in children with bilateral spastic cerebral palsy.
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Comparateur actif: Conventional Physiotherapy
Participants will receive conventional physiotherapy for 12 weeks, 3 sessions per week.
The rehabilitation program will include stretching exercises, strengthening exercises, balance training, and functional task-oriented activities.
The intervention will follow the same duration and frequency as the experimental group but without treadmill gait training.
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A rehabilitation program including stretching, strengthening, balance training, and functional activities aimed at improving mobility and motor function in children with bilateral spastic cerebral palsy.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Gross Motor Function Measure-66 (GMFM-66) Score
Délai: Baseline and Week 12
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The Gross Motor Function Measure-66 (GMFM-66) is a standardized and validated observational assessment used to evaluate changes in gross motor function in children with cerebral palsy.
This study will assess changes in the Standing (Dimension D) and Walking, Running, and Jumping (Dimension E) domains to evaluate improvements in functional mobility and gait-related abilities.
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Baseline and Week 12
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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MAS
Délai: Baseline and Week 12
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randomised controlled trial
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Baseline and Week 12
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Change in 10 Meter Walk Test (10MWT) Walking Velocity
Délai: Baseline and Week 12
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The 10 Meter Walk Test measures walking speed over a 10-meter distance.
Walking velocity (meters/second) will be assessed to determine changes in gait speed and locomotor efficiency following intervention.
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Baseline and Week 12
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Change in Timed Up and Go Test (TUG) Performance
Délai: Baseline and Week 12
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The Timed Up and Go Test measures functional mobility and dynamic balance by recording the time required to stand from a chair, walk 3 meters, turn, return, and sit down.
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Baseline and Week 12
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Change in Pediatric Balance Scale (PBS) Score
Délai: Baseline and Week 12
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The Pediatric Balance Scale is a 14-item performance-based measure used to assess functional balance abilities in children.
Changes in balance performance will be evaluated following the intervention.
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Baseline and Week 12
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Change in Modified Ashworth Scale (MAS) Score
Délai: Baseline and Week 12
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The Modified Ashworth Scale is an ordinal clinical scale used to assess changes in muscle spasticity.
Lower-limb muscle groups including hip adductors, hamstrings, and gastrocnemius-soleus muscles will be evaluated.
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Baseline and Week 12
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Change in 6 Minute Walk Test (6MWT) Distance
Délai: Baseline and Week 12
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The 6 Minute Walk Test measures walking endurance by recording the total distance walked in 6 minutes.
It will be used to evaluate changes in functional walking capacity.
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Baseline and Week 12
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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MAS
Délai: Baseline and Week 12
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randomised controlled trial
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Baseline and Week 12
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Dr. Tehreem Jameel, DPT; PGD-PPT, Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
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
- Alotaibi A, Ibrahim A, Ahmed R, Abualait T. Effectiveness of Partial Body Weight-Supported Treadmill Training on Various Outcomes in Different Contexts among Children and Adolescents with Cerebral Palsy: A Systematic Review and Meta-Analysis. Children (Basel). 2023 Dec 20;11(1):9. doi: 10.3390/children11010009.
- Chen Y, Li X, Wang L, et al. Effects of neuromuscular and physical therapy interventions on lower limb spasticity and gait performance in children with cerebral palsy: systematic review and meta-analysis. Front Pediatr. 2023;11:1185672.
- Desloovere K, Molenaers G, Feys H, et al. Evidence-based interventions for improving gait function in children with cerebral palsy: clinical perspectives and rehabilitation approaches. Dev Med Child Neurol. 2021;63(5):567-575.
- Liang X, Tan Z, Yun G, Cao J, Wang J, Liu Q, Chen T. Effectiveness of exercise interventions for children with cerebral palsy: A systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2021 Apr 1;53(4):jrm00176. doi: 10.2340/16501977-2772.
- Han YG, Yun CK. Effectiveness of treadmill training on gait function in children with cerebral palsy: meta-analysis. J Exerc Rehabil. 2020 Feb 26;16(1):10-19. doi: 10.12965/jer.1938748.374. eCollection 2020 Feb.
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)
1 février 2026
Achèvement primaire (Réel)
30 avril 2026
Achèvement de l'étude (Réel)
15 juillet 2026
Dates d'inscription aux études
Première soumission
27 juin 2026
Première soumission répondant aux critères de contrôle qualité
27 juin 2026
Première publication (Réel)
6 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 003-SKJWF-2026
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 with other researchers due to ethical considerations, participant confidentiality, and data protection requirements.
The collected data will be used solely for the purposes specified in this study protocol.
De-identified aggregated results will be reported in scientific publications and presentations to contribute to evidence-based rehabilitation practice.
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 .