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

Syeda Khatoon e Jannat Welfare Foundation24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Gross Motor Function Measure-66 (GMFM-66) Score

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.