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Completed
NCT07683338
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
Conditions: Bilateral Spastic Cerebral Palsy, Cerebral Palsy, Spasticity Due to Cerebral Palsy, Gait Abnormality, Mmotor Function Impairment
Sex: All
Ages: 6 Years – 16 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Syeda Khatoon e Jannat Welfare Foundation
Location: Syeda Khatoon e Jannat Trust Hospital & Special Education Centre Faisalabad Punjab Province
Summary
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07683338). StuddyBuddy aggregates publicly available trial information.