Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
Faisalabad, Punjab Province, 3800, Pakistan
NCT Number: NCT07683338
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.
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Notify Me6 year–16 year
All sexes
Interventional
Not applicable
Faisalabad, Punjab Province, 3800, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
randomised controlled trial
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
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.
Time frame: Baseline and Week 12
randomised controlled trial
Syeda Khatoon e Jannat Welfare Foundation
Other
Acronym: GAIT-CP
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