Effect of Treadmill Gait Training Combined With Conventional Physiotherapy on Gait Performance an… (NCT07683338) | Clinical Trial Compass
CompletedNot Applicable
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
Pakistan24 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
6 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gross Motor Function Measure-66 (GMFM-66) Score