Bilateral Spastic Cerebral Palsy, Cerebral Palsy, Gait Abnormality, Mmotor Function Impairment, Spasticity Due to Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Treadmill Training, Gait Training, Neurorehabilitation, Gross Motor Function
Brief 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.
Detailed description
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.
Interventions
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.
OTHERConventional 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.
Sponsors
Syeda Khatoon e Jannat Welfare Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to group allocation to reduce measurement bias. Participants and care providers will not be blinded due to the nature of the rehabilitation intervention.
Intervention model description
Participants will be randomly allocated into two parallel groups: treadmill gait training combined with conventional physiotherapy and conventional physiotherapy alone.
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gross Motor Function Measure-66 (GMFM-66) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAS | Baseline and Week 12 | randomised controlled trial |
| Change in 10 Meter Walk Test (10MWT) Walking Velocity | 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. |
| Change in Timed Up and Go Test (TUG) Performance | 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. |
| Change in Pediatric Balance Scale (PBS) Score | 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. |
| Change in Modified Ashworth Scale (MAS) Score | 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. |
| Change in 6 Minute Walk Test (6MWT) Distance | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr. Tehreem Jameel, DPT; PGD-PPT
Syeda Khatoon e Jannat Trust Hospital & Special Education Centre
Outcome results
None listed