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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
24
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Gross Motor Function Measure-66 (GMFM-66) Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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MAS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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MAS
Tidsramme: Baseline and Week 12
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randomised controlled trial
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Baseline and Week 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Dr. Tehreem Jameel, DPT; PGD-PPT, Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2026
Primær fullføring (Faktiske)
30. april 2026
Studiet fullført (Faktiske)
15. juli 2026
Datoer for studieregistrering
Først innsendt
27. juni 2026
Først innsendt som oppfylte QC-kriteriene
27. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 003-SKJWF-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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