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 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
24
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Gross Motor Function Measure-66 (GMFM-66) Score
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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MAS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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MAS
Tijdsspanne: Baseline and Week 12
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randomised controlled trial
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Baseline and Week 12
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Dr. Tehreem Jameel, DPT; PGD-PPT, Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 februari 2026
Primaire voltooiing (Werkelijk)
30 april 2026
Studie voltooiing (Werkelijk)
15 juli 2026
Studieregistratiedata
Eerst ingediend
27 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 juni 2026
Eerst geplaatst (Werkelijk)
6 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
21 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 003-SKJWF-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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